We present the updated recommendations from the Société française de radiothérapie oncologique (SFRO, the French society for radiation oncology) regarding radiation dose constraints for organs at risk in adult patients, with the aim of supporting clinical decision-making in contemporary radiotherapy practice. These guidelines address a wide range of clinical scenarios, including normofractionation, hypofractionation, stereotactic radiotherapy, and reirradiation. Dose constraints are essential to ensure both the safety and efficacy of radiotherapy, especially with the growing use of advanced techniques such as intensity-modulated radiotherapy and stereotactic body radiotherapy. However, given the wide range of existing dose constraints and the lack of harmonization across different practices, this work aims to provide a unified and updated framework adapted to modern radiotherapy techniques. Moreover, many of these constraints are still based on data derived from three-dimensional conformal radiotherapy, which necessitates cautious application when extrapolated to more advanced techniques. Clinical judgment remains crucial, particularly in complex cases such as re-irradiation or treatments using altered fractionation schedules. These updated consensus aim to provide a practical and evidence-based framework to help radiation oncologists and medical physicists minimize the risk of toxicity to normal tissues. By consolidating and adapting current knowledge to modern radiotherapy techniques, they serve as a useful tool in daily clinical practice.
BACKGROUND:The management of oligorecurrent pelvic lymph nodes in patients with prostate cancer is debated. Intermittent androgen-deprivation therapy (ADT; IADT) is often proposed. Elective pelvis irradiation (ENRT) may prolong tumor control and decrease subsequent spread. OBJECTIVE:To assess the efficacy of a combination of 6 mo of IADT with or without ENRT to treat patients with oligorecurrent pelvic and para-aortic lymph nodes of prostate cancer. DESIGN, SETTING, AND PARTICIPANTS:The OLIGOPELVIS 2-GETUG P12 trial is a multicenter randomized phase 3 trial, randomizing patients with 1-5 oligorecurrent pelvic and/or para-aortic lymph nodes of prostate cancer between arm A (IADT alone for 6 mo) versus arm B (salvage pelvic image-guided intensity-modulated radiotherapy [IG-IMRT], 54 Gy, 30 fractions to the pelvis and 66 Gy, 30 fractions to the lymph nodes) combined with IADT). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:The primary outcome is progression-free survival, defined as the time from randomization until a biochemical-clinical failure is detected or death from any cause. In total, 256 patients will be included. RESULTS AND LIMITATIONS:In this population of patients requiring ADT, ENRT may demonstrate antitumoral efficacy while achieving acceptable toxicity and maintaining quality of life. Limitations are mainly inherent to the open-label design of this study. CONCLUSIONS:This phase 3 study will explore the role of salvage pelvic IG-IMRT combined with IADT in patients with oligorecurrent pelvic lymph nodes of prostate cancer in prolonging the first failure-free interval between the first and the second IADT courses. PATIENT SUMMARY:The OLIGOPELVIS 2-GETUG P12 clinical trial assesses short-term (6 mo) androgen-deprivation therapy in association with external beam radiation therapy in men with prostate cancer relapsing to pelvic and para-aortic lymph nodes of prostate cancer. The trial investigates whether radiotherapy targeting pelvic and para-aortic lymph nodes can improve the biological response while maintaining a favorable tolerability profile. TRIAL REGISTRATION:NCT03630666, RCB 2018-A00551-54, date of registration: 2018-12-04.
TPS8128 Background: Patients with unresectable stage III non-small cell lung cancer (NSCLC) who are elderly or have significant comorbidities are frequently ineligible for concurrent chemoradiotherapy (CCRT). Sequential chemoradiotherapy (seq-CRT) remains the preferred approach in this population. While consolidation immunotherapy after CCRT improves survival, evidence supporting its optimal integration with seq-CRT is limited. Preclinical and clinical data suggest that combining chemotherapy and immunotherapy enhances tumor immunogenicity through increased antigen release, immune priming, and modulation of the tumor microenvironment. Hypofractionated radiotherapy may further potentiate immune-mediated effects while shortening overall treatment duration, which is particularly relevant for frail patients. The IFCT-2401 SPORADIC trial evaluates in unfit or elderly patients a sequential strategy integrating neoadjuvant chemo-immunotherapy prior to hypofractionated radiotherapy, followed by maintenance immunotherapy, in patients with unresectable stage III NSCLC not eligible for CCRT. Exploratory correlative studies include circulating biomarkers, immune profiling, lymphopenia, and metabolic response assessment. Methods: IFCT-2401 SPORADIC is a multicenter, randomized, open-label phase II trial (EU-CT 2024-517316-29-00). Patients are randomized in a 2:1 ratio to receive neoadjuvant chemotherapy alone (arm A) or neoadjuvant chemo-immunotherapy (arm B). Neoadjuvant treatment consists of three 28-day cycles of carboplatin (AUC 5, day 1) and paclitaxel (80 mg/m², days 1, 8 and 15). Cemiplimab (350 mg, every 3 weeks) is added in arm B. All patients subsequently receive curative hypofractionated thoracic radiotherapy (55 Gy in 20 fractions), followed by maintenance cemiplimab every 3 weeks for up to 12 months. Eligible patients have unresectable stage IIIA–C NSCLC. Three categories of patients are considered unfit for CCRT: age ≥70 years with ECOG performance status (PS) 0 to 1, age < 70 years with ECOG PS 0 to 1 and significant comorbidities or age < 70 years with ECOG PS 2. Key exclusion criteria include actionable oncogenic drivers, prior systemic therapy for NSCLC and active autoimmune disease. The primary endpoint is progression-free survival. A total of 152 patients are planned for enrollment across 25 centers. First patient was enrolled on November 17, 2025. Clinical trial information: EU-CT 2024-517316-29-00.
PURPOSE:This study aimed to present the clinical workflow developed for stereotactic arrhythmia radioablation, with a particular focus on the inHEART multimodality platform used for cardiac imaging integration and 3-dimensional substrate segmentation. We also report the clinical outcomes and dosimetric results of the initial 18 patients treated. METHODS AND MATERIALS:All patients underwent contrast-enhanced cardiac computed tomography, including late-enhancement imaging and optional cardiac magnetic resonance imaging. Imaging data were processed using the inHEART multimodality platform for specific imaging in cardiology (MUSIC), which enabled automatic 3-dimensional segmentation of cardiac anatomy, identification of the scar substrate, and integration of electrophysiological data to define the clinical target volume. The stereotactic body radiation therapy inHEART module exported target structures in digital imaging and communications in medicine-radiation therapy format to the Eclipse Treatment Planning System. Three-dimensional computed tomography simulation scans were acquired to account for cardiorespiratory motion, and an internal target volume/planning target volume (PTV) was derived accordingly on expiratory phases. Treatment was delivered with volumetric modulated arc therapy in a single fraction of 25 Gy to the PTV using a TrueBeam STx linac. Clinical effectiveness was assessed through ventricular tachycardia (VT) burden and implantable cardioverter defibrillators shock reduction. RESULTS:Median clinical target volume, internal target volume, and PTV volume were 14.50 cc (range, 4.32-32.6 cc), 22.13 cc (range, 5.15-49.15 cc), and 58.42 cc (range, 20.87-109.76 cc), respectively. Excellent dose coverage was achieved, median PTV D99% was 25.25 Gy (range, 21.94-27.51 Gy), with a mean Paddick conformity index of 0.89 ± 0.08. All organs at risk met the dose constraints. At 12 months, 78% of patients showed >75% VT reduction, and 94% of surviving patients experienced a limited number of shocks (<2). CONCLUSIONS:Integrating the inHEART stereotactic body radiation therapy module within a standardized multimodal imaging workflow enables accurate stereotactic arrhythmia radioablation planning and delivery. This approach proved feasible, robust, and safe for managing refractory VT.
BACKGROUND AND OBJECTIVE:Muscle-invasive bladder cancer (MIBC) may present de novo (primary MIBC [pMIBC]) or progress from non-muscle-invasive disease (secondary MIBC [sMIBC]). While sMIBC has been associated with adverse outcomes after radical cystectomy, its prognostic impact in patients undergoing trimodal therapy (TMT) is unclear. We aimed to compare the outcomes between pMIBC and sMIBC in a multicenter cohort treated with bladder-preserving TMT. METHODS:We conducted a retrospective study including patients with MIBC treated with curative-intent TMT. Eligible patients had stage ≥T2 disease and completed TMT without discontinuation. Patients were classified as those having pMIBC (≥T2 at diagnosis) or sMIBC (progression after prior non-muscle-invasive bladder cancer [NMIBC]). The primary endpoint was recurrence-free survival; the secondary endpoints were metastasis-free survival, cancer-specific survival (CSS), overall survival, and treatment-related toxicity. Survival was assessed using Kaplan-Meier methods and multivariable Cox regression. KEY FINDINGS AND LIMITATIONS:Among 294 patients (234 with pMIBC and 60 with sMIBC), the median age was 77 yr. The median follow-up was 34 mo for pMIBC and 24 mo for sMIBC. The 3-yr CSS rate was 78% for pMIBC and 79% for sMIBC. After adjustment for clinical covariates, sMIBC was not associated with an increased risk of recurrence (hazard ratio [HR] 1.35, 95% confidence interval [CI] 0.85-2.13) and cancer-specific death (HR 0.88, 95% CI 0.44-1.76). Toxicities were mostly of grade 1-2; grade ≥3 events were rare. Limitations include the retrospective design, a smaller sMIBC subgroup, and a relatively short follow-up. CONCLUSIONS AND CLINICAL IMPLICATIONS:Outcomes after TMT were broadly similar between pMIBC and sMIBC, although overall survival was lower in patients with secondary disease. A prior NMIBC history should therefore not preclude consideration of bladder-preserving therapy in appropriately selected patients.
PURPOSE:/objective: Limited pelvic/para-aortic nodal relapse of prostate cancer after radical local treatment remains a major challenge for locoregional salvage strategies. Salvage Elective Nodes radiotherapy (ENRT) is an appealing option, but concerns persist regarding its toxicity. This study evaluates the 18-months toxicity profile of salvage ENRT combined with intermittent androgen deprivation therapy (iADT) in patients with pelvic and para-aortic oligometastatic disease, compared with iADT alone. MATERIAL:/Methods: OLIGOPELVIS-2/GETUG P12 was a prospective, multicenter, randomized phase III trial. Patients were randomized 1:1 to arm A (6-months iADT alone) or arm B (6-months iADT + ENRT: 54 Gy/1.8 Gy per fraction to the pelvic lymph nodes and 66 Gy/2.2 Gy per fraction to pathological nodes). ENRT started after three months of iADT. After analyzing relapse patterns in the OLIGOPELVIS GETUG P07 study, a December 22, 2021 amendment permitted the inclusion of para-aortic lymph nodes and extended irradiation fields up to the renal arteries. Toxicity was defined using NCI-CTCAE v4.0. RESULTS:A total of 256 patients were enrolled across 17 French centers between 12/2018 and 05/2023. The safety population included 127 patients in arm A and 121 in arm B. Eight patients in arm B were excluded as they did not ultimately receive radiotherapy. Prior prostate or prostatic bed irradiation was reported in 57% and 55% of patients, respectively. In arm B, 39 patients also received para-aortic irradiation. At 6 months, grade ≥ 2 genitourinary (GU) and gastrointestinal (GI) toxicities occurred in 2.4% vs 9.9% (p = 0.02) and 0% vs 19.8% (p < 0.001) of patients in arms A and B, respectively. At 18 months, grade ≥ 2 GU toxicity was 4.1% vs 10.7%, (p = 0.04) in arms A and B, respectively, while no difference in GI toxicity was observed. Prior prostate or prostatic bed irradiation did not increase toxicity at any time point. Among patients receiving para-aortic irradiation, compared to those without : grade ≥ 2 toxicity was similar at 6 months (GU: 12.8% vs 8.5%, p = 0.8; GI: 20.5% vs 19.5%, p = 0.9), or at 18 months (GU: 10.3% vs 11%, p = 1.0; GI: 0% vs 6.1%, p = 0.17), though 6 months upper grade ≥ 1 GI disorders were more frequent (25.6% vs 9.8%, p = 0.02). CONCLUSIONS:Eighteen-month toxicity of salvage ENRT with a simultaneous boost to the pathological lymph nodes, associated with 6-months iADT was acceptable, even among patients with prior prostate irradiation or additional para-aortic irradiation (NCT03630666- RCB 2018-A00551-54; FundingPHRC-K 16-129).
PURPOSE:Trimodal therapy, combining transurethral resection of the bladder tumour, radiotherapy, and concurrent radiosensitization, is an established bladder-preserving alternative to radical cystectomy in muscle-invasive bladder cancer. Hypofractionated radiotherapy has gained interest due to radiobiological advantages and logistical convenience, yet its efficacy and safety remain under evaluation. METHODS:A review of prospective phase II and III trials published between 2000 and 2025 was conducted in Medline using the search engine PubMed. Studies were included if they assessed hypofractionated radiotherapy (excluding stereotactic body radiotherapy) for non-metastatic muscle-invasive bladder cancer within a curative-intent using a trimodal therapy approach. Key endpoints included progression-free survival, overall survival, and toxicity. RESULTS:Seven prospective trials (five phase II, two phase III) were identified. The largest evidence come from the BC2001 and BCON trials, which demonstrated that a dose of 55Gy delivered in 20 fractions was non-inferior to a dose of 64Gy delivered in 32 fractions in terms of locoregional control and overall survival, with similar genitourinary and gastrointestinal toxicity rates. Additional studies confirmed comparable efficacy between hypofractionated and conventional fractionated radiotherapy regimens. Various concurrent systemic therapies were used, including cisplatin, 5-fluorouracil with mitomycin C, gemcitabine, and carbogen with nicotinamide, though no regimen showed clear superiority. Elective pelvic nodes irradiation remains controversial; one phase III trial showed no benefit, while recent data suggest a potential survival advantage without increased toxicity, even in hypofractionated protocols. CONCLUSION:Hypofractionated chemoradiotherapy is a safe and effective bladder-preserving strategy in selected patients with muscle-invasive bladder cancer. It offers comparable oncological outcomes and toxicity to conventional radiotherapy, with improved treatment efficiency. While systemic radiosensitization remains essential, further research is needed to optimize agents and clarify the role of pelvic nodes irradiation in hypofractionated settings.
BACKGROUND AND OBJECTIVE:Few studies have compared short-term androgen deprivation (STADT) combined with high-dose radiotherapy (STADT-RT) versus high-dose radiotherapy (RT) alone in localized prostate cancer. METHODS:The GETUG 14 study randomized 376 patients to RT (n = 191) or STADT-RT (n = 179). The RT dose was 80 Gy in both arms. STADT consisted of monthly triptorelin and daily flutamide for a total duration of 4 mo, starting 2 mo before RT. Disease-free survival (DFS) was the primary endpoint. Secondary endpoints were overall survival (OS), biochemical failure (BF), metastasis failure (MF), toxicity, and quality of life. KEY FINDINGS AND LIMITATIONS:Among the 370 patients in the modified intention-to-treat population, 241 (65%) had intermediate-risk and 107 (28%) high-risk prostate cancer. At median follow-up among surviving patients of 84 mo (interquartile range 62-99 mo), the 5-yr DFS rate was 76% in RT arm versus 84% in STADT-RT arm (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.43-0.94]). ADT addition decreased BF (HR 0.45, 95% CI 0.28-0.72) and MF (HR 0.5, 95% CI 0.23-1.11) but not OS (HR 1.22, 95% CI 0.65-2.29). There were no significant differences for RT versus STADT-RT in the incidence rates for grade ≥2 toxicity in terms of acute gastrointestinal (GI) toxicity (26%, 95% CI 20-32 vs 26%, 95% CI 20-33), acute genitourinary (GU) toxicity (39%, 95% CI 32-46% vs 42%, 95% CI 35-50%), late GI toxicity (21%, 95% CI 16-28% vs 23%, 95% CI 18-30%), or late GU toxicity (30%, 95% CI 24-38% vs 27%, 95% CI 21-34%). CONCLUSIONS AND CLINICAL IMPLICATIONS:STADT is a well-tolerated and effective strategy that can enhance oncological outcomes when combined with high-dose RT, particularly for patients with intermediate- or high-risk prostate cancer.
Herein are presented the update of the recommendations from the Société française de radiothérapie oncologique (the French society for radiation oncology) regarding the indications and methods of lung cancer radiotherapy. The recommendations for delineation of the target volumes and organs at risk are detailed.
The process of reirradiation in oncology presents a distinctive set of challenges, wherein clinical decision-making is predicated on a delicate balancing act between the efficacy of the treatment and the risk of severe toxicity. Despite the paucity of randomized and prospective data, an increasing number of clinical guidelines encourage its consideration for patients with local or metastatic recurrence. While awaiting dedicated guidance from international scientific societies, the following publication is based on the guidelines and multicentre reflections of the Recommendations Commission of the Société française de radiothérapie oncologique (SFRO, the French society for radiation oncology). It addresses key questions related to reirradiation, with a particular focus on prostate, gynaecological and pelvic tumours.
Cette revue de la littérature a pour objectif d’évaluer l’incidence, l’impact clinique et les options thérapeutiques disponibles pour la prise en charge de la gynécomastie induite par l’hormonothérapie, en particulier à l’ère des inhibiteurs de la voie des récepteurs aux androgènes chez les patients atteints de cancer de la prostate. Nous avons analysé les données issues d’essais cliniques, portant sur l’incidence de la gynécomastie sous traitement par les inhibiteurs de la voie des récepteurs aux androgènes et l’efficacité des stratégies prophylactiques et curatives, principalement le tamoxifène et la radiothérapie mammaire, chez les patients recevant du bicalutamide. Les inhibiteurs de la voie des récepteurs aux androgènes en monothérapie induisent des taux élevés de gynécomastie (34 à 55 %), alors que l’association à une castration chimique réduit ce risque. Le tamoxifène prophylactique diminue significativement l’incidence de la gynécomastie (jusqu’à 10 % contre 73 % sans traitement), avec une bonne tolérance ; la radiothérapie mammaire prophylactique montre également une efficacité. En traitement à visée curative, le tamoxifène semble plus efficace que la radiothérapie. La chirurgie reste une option invasive de recours. Cependant, l’extrapolation aux inhibiteurs de la voie des récepteurs aux androgènes des résultats obtenus avec le bicalutamide demeure incertaine, en raison de différences pharmacologiques et cliniques. La gynécomastie pourrait devenir une complication majeure des inhibiteurs de la voie des récepteurs aux androgènes en monothérapie. À ce jour, le tamoxifène et la radiothérapie mammaire prophylactique sont les stratégies les mieux validées, le tamoxifène semblant plus efficace. De nouvelles études sont nécessaires pour confirmer leur efficacité et leur sécurité spécifique chez les patients recevant des inhibiteurs de la voie des récepteurs aux androgènes.
Le traitement des cancers bronchopulmonaires de stade III non résécables repose actuellement sur une association chimiothérapie-radiothérapie, idéalement concomitante, suivie d'une consolidation par durvalumab administré pendant 1 an. Même si ce nouveau standard thérapeutique illustre les progrès techniques de l'irradiation thoracique et l'impact positif des anti-PD-L1 dans le contexte des stades localement avancés, les résultats (survie sans progression de 34 % à 5 ans et survie à 43 % à 5 ans, absence de bénéfice de survie en l'absence d'expression de PD-L1 ou en cas de mutation de l'EGFR) soulignent la nécessité d'un progrès thérapeutique. Celui-ci pourrait passer par l'optimisation des stratégies d'association de l'immunothérapie à la chimioradiothérapie, la redéfinition des paramètres de la radiothérapie thoracique afin de favoriser la synergie avec l'immunothérapie et l'intégration des traitements ciblés dans la stratégie thérapeutique en cas d'addiction oncogénique.
Background:Management of prostate cancer (PCa) patients with lung oligometastases remains unclear in the absence of published data. Objective:The aim of this study was to evaluate the efficacy of Stereotactic Body Radiotherapy (SBRT) in this setting. Design setting and participants:We conducted a multicenter retrospective study that included 35 PCa patients treated with SBRT for lung oligometastases in 7 centers across 3 countries. Outcome measurements and statistical analysis:The efficacy was evaluated by the progression free-survival (PFS), defined as pre-SBRT PSA + 25 % or nadir PSA + 25 % and + 2 ng/mL or radiological progression if it occurred before biochemical progression. The local recurrence free-survival (LRFS), distant metastases free-survival (DMFS), Overall Survival (OS) and Androgen Deprivation Therapy free-survival were also assessed. Survival was estimated using the Kaplan Meier method. Results:35 patients were included with lung oligometastases staged with PET-CT for 97 % and histologically biopsy confirmed for 51 %. 77 % had an oligorecurrent metastatic disease. The median pre SBRT PSA was at 1.7 ng/mL [0.8, 3.0] and the median follow-up after SBRT was 28.7 months. The median PFS was 21.6 months [95 %CI: 21.6; NA] and the median DMFS was 32.4 months [95 %CI: 22.2-NA]. No parameters were significantly associated with PFS on the univariate and multivariate models.For patients who did not start ADT before or concomitantly with SBRT (n = 18), the 1-year ADT free-survival rate was estimated at 87.2 % [71.9;100]. Conclusions:SBRT for PCa lung oligometastases offers good oncological outcomes, comparable to those reported for bone and/or lymph node metastases SBRT. Our results encourage the inclusion of patients with lung oligometastatic disease in clinical trials designed to assess the value of SBRT. Patient summary:SBRT for prostate cancer lung oligometastases shows promising results, similar to treatments for bone or lymph node oligometastases.
PURPOSE:To evaluate the safety and efficacy of the flattening filter-free (FFF) technique compared with the flattening filter (FF) technique in the context of lung tumor stereotactic body radiation therapy (SBRT). METHODS AND MATERIALS:The study included a total of 101 lung SBRT treatments among 82 consecutive patients. Patients were treated with an FF technique (FF group, n = 47) between 2012 and 2014 and with an FFF technique (FFF group, n = 54) between 2014 and 2016. Our risk-adapted SBRT fractionation protocol based on location (3 or 5 fractions) remained unchanged during the entire study. Treatment plans consisted of a dynamic conformal half-arc, and the dose was prescribed to the 80% isodose line. FFF treatments are delivered 2.33 times faster than FF treatments because of the higher dose rate of the machine. RESULTS:The median follow-up for the 82 patients was 55.4 months, and the median overall survival for all patients was 45.9 months. Local control at 2 years post-SBRT of the 101 lesions was excellent and similar in both groups (97.9% in the FF group vs 98.1% in the FFF group). There were no grade 4 or 5 toxicities and only 4 grade 3 lung toxicities (4.1%) in the FF group (vs none in the FFF group). Three patients in the FFF group versus 1 patient in the FF group had a symptomatic rib fracture. Among patients treated free breathing on a single lesion (n = 65), the local recurrence-free survival at 2 years was 85.7% (95% CI, 62.0-95.2) in the FFF group and 71.4% (95% CI, 52-84.1) in the FF group (P = .139). CONCLUSIONS:Patient treatment with lung SBRT using the FFF technique is safe and provides an excellent long-term local control and low toxicity compared with the FF technique.
This review aims to evaluate the incidence, clinical impact, and available therapeutic options for the management of gynecomastia induced by hormonal therapy, particularly in the era of androgen receptor pathway inhibitors, in patients with prostate cancer. We analysed data from clinical trials evaluating the incidence of gynecomastia under androgen receptor pathway inhibitors and the efficacy of both prophylactic and curative strategies, primarily tamoxifen and male breast radiotherapy, in patients receiving bicalutamide. Androgen receptor pathway inhibitors monotherapy is associated with high rates of gynecomastia (34 to 55 %), whereas combining androgen receptor pathway inhibitors with chemical castration significantly reduces this risk. Prophylactic tamoxifen significantly decreases gynecomastia incidence (down to 10 % versus 73 % without treatment) with good overall tolerance; prophylactic breast radiotherapy also shows efficacy. In the curative setting, tamoxifen appears more effective than radiotherapy, while surgery remains an invasive fallback option. However, extrapolating results obtained with bicalutamide to second-generation androgen receptor pathway inhibitors remains uncertain due to pharmacological and clinical differences. Gynecomastia could become a major complication of androgen receptor pathway inhibitors monotherapy. To date, tamoxifen and prophylactic breast radiotherapy are the most validated strategies, with the former appearing more effective. Further studies are needed to confirm their specific efficacy and safety in patients treated with androgen receptor pathway inhibitors.
Pulmonary metastases are a common site of spread for many cancers, regardless of the primary tumour. While systemic treatments remain the standard of care, local therapies, particularly stereotactic body radiotherapy, have shown promising results in terms of local control and survival in selected patients with oligometastatic disease. This document presents the updated recommendations from the Société française de radiothérapie oncologique (SFRO, French society for radiation oncology) regarding the indications and technical aspects of radiotherapy for intrapulmonary metastases. The focus is on stereotactic body radiotherapy, including patient selection criteria, prescription protocols, treatment planning, respiratory motion management, and organ-at-risk constraints. Alternative approaches, such as moderately hypofractionated palliative radiotherapy, are also discussed for cases where stereotactic body radiotherapy is not feasible. These recommendations aim to guide clinical practice and promote the safe and effective use of high-precision radiotherapy for pulmonary metastases.
Purpose Radiotherapy quality assurance (RTQA) is essential for ensuring adherence to trial protocols. This paper summarizes the individual case review (ICR) results from the PEACE-1 trial, a phase-III study investigates standard of care (androgen deprivation therapy with or without docetaxel) with or without local radiotherapy; and with or without abiraterone acetate plus prednisone in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Materials and methods Participating institutions submitted radiotherapy (RT) plans for central review, assessing protocol compliance in target volume and organs at risk (OARs) delineation, as well as dose specifications. ICRs were conducted either retrospectively (r-ICRs), after starting RT, or prospectively (p-ICRs), before RT initiation. Case reviews were categorized as acceptable per protocol, acceptable variation, or unacceptable variation based on delineation and dose and plan parameters. Results Out of 585 patients in the RT arms, 527 (90%) had r-ICRs, primarily using intensity-modulated radiotherapy (IMRT). Delineation review approved 417 (87%) r-ICRs and 44 (92%) p-ICRs. The main reasons for unacceptable delineation were erroneous clinical target volume (CTV) delineation. In dose and plan reviews, 399 (96%) r-ICRs cases and 46 (96%) p-ICRs were approved, with unacceptable cases primarily due to PTV dose distribution issues. Conclusion RTQA is crucial in prostate cancer trials, primarily for proper target volume delineation. It is recommended to omit r-ICRs due to resource demands and lack of impact on RTQA outcomes, using limited p-ICRs with early feedback for site deviations and reserving full p-ICRs for trails with new techniques or dose regimens.ClinicalTrials.gov: NCT01957436.
BACKGROUND AND PURPOSE:Patients with muscle-invasive bladder cancer (MIBC) treated with radical cystectomy remain at significant risk of pelvic recurrence. We aim to report acute toxicity from a multicentric phase II randomized trial evaluating adjuvant radiotherapy (ART). MATERIALS AND METHODS:Patients with pathological high-risk urothelial MIBC, defined as pT3a-4b and/or pN1-2 and/or positive surgical margins, were randomized (3:1) between ART (arm A) and observation (arm B). ART consisted of IMRT (50.4 Gy / 28 fractions) to the pelvic lymph nodes ± cystectomy bed. The primary endpoint was pelvic recurrence-free survival. Herein, we report on acute toxicity (< 6 months after treatment) using the NCI CTCAE 4.0. RESULTS:From May 2018 to December 2023, 80 eligible patients from 19 centres across France were enrolled: 58 in arm A and 22 in arm B. The present safety analysis focuses on 74 patients: 52 patients in arm A who effectively initiated ART and 22 in arm B. The median age was 66 years. Chemotherapy (mostly neoadjuvant) was given in 62.2 %. All the patients in the arm A completed the treatment. The rate of grade ≥ 2 and grade ≥ 3 acute gastro-intestinal adverse events (AEs) was 28.8 % and 3.8 %, respectively in arm A, and 4.5 % and 0 % respectively in arm B. Of the two grade ≥ 3 GI AE observed in arm A, one was attributed to surgical complications and the other to disease progression. The rate of grade ≥ 2 and grade ≥ 3 acute urinary AEs was 5.8 % and 0 %, respectively in arm A, and 9.1 % and 4.5 % respectively in arm B. As exploratory analyses, when focusing on AE of grade ≥ 2, these proportions were greater for Arm A (28.8 % [n = 15] vs. 4.5 % [n = 1]; p = 0.028, Fisher's exact test). Overall, no radiotherapy-related grade ≥ 3 AE was observed. CONCLUSION:From a randomized multicentric phase II trial, despite a logical higher rate of radiotherapy-related AE in the experimental arm, low rates of moderate to severe acute toxicity suggest the safety of ART for pathological high-risk MIBC. Efficacy end-points results are awaited.