BACKGROUND:The aim of this trial was to compare dose-escalated conformal radiotherapy with control-dose conformal radiotherapy in patients with localised prostate cancer. Preliminary findings reported after 5 years of follow-up showed that escalated-dose conformal radiotherapy improved biochemical progression-free survival. Based on the sample size calculation, we planned to analyse overall survival when 190 deaths occurred; this target has now been reached, after a median 10 years of follow-up. METHODS:RT01 was a phase 3, open-label, international, randomised controlled trial enrolling men with histologically confirmed T1b-T3a, N0, M0 prostate cancer with prostate specific antigen of less than 50 ng/mL. Patients were randomly assigned centrally in a 1:1 ratio, using a computer-based minimisation algorithm stratifying by risk of seminal vesicle invasion and centre to either the control group (64 Gy in 32 fractions, the standard dose at the time the trial was designed) or the escalated-dose group (74 Gy in 37 fractions). Neither patients nor investigators were masked to assignment. All patients received neoadjuvant androgen deprivation therapy for 3-6 months before the start of conformal radiotherapy, which continued until the end of conformal radiotherapy. The coprimary outcome measures were biochemical progression-free survival and overall survival. All analyses were done on an intention-to-treat basis. Treatment-related side-effects have been reported previously. This trial is registered, number ISRCTN47772397. FINDINGS:Between Jan 7, 1998, and Dec 20, 2001, 862 men were registered and 843 subsequently randomly assigned: 422 to the escalated-dose group and 421 to the control group. As of Aug 2, 2011, 236 deaths had occurred: 118 in each group. Median follow-up was 10·0 years (IQR 9·1-10·8). Overall survival at 10 years was 71% (95% CI 66-75) in each group (hazard ratio [HR] 0·99, 95% CI 0·77-1·28; p=0·96). Biochemical progression or progressive disease occurred in 391 patients (221 [57%] in the control group and 170 [43%] in the escalated-dose group). At 10 years, biochemical progression-free survival was 43% (95% CI 38-48) in the control group and 55% (50-61) in the escalated-dose group (HR 0·69, 95% CI 0·56-0·84; p=0·0003). INTERPRETATION:At a median follow-up of 10 years, escalated-dose conformal radiotherapy with neoadjuvant androgen deprivation therapy showed an advantage in biochemical progression-free survival, but this advantage did not translate into an improvement in overall survival. These efficacy data for escalated-dose treatment must be weighed against the increase in acute and late toxicities associated with the escalated dose and emphasise the importance of use of appropriate modern radiotherapy methods to reduce side-effects. FUNDING:UK Medical Research Council.

Abstract Background International standard adjuvant radiotherapy regimens following primary surgery for early breast cancer have historically delivered a high total dose (50Gy) in 25 small daily doses (fractions) over 5 weeks, however randomised trials, including START, indicate that a lower total dose delivered in fewer, larger fractions (Fr) is likely to be at least as safe and effective (START Trialists' Group, Lancet 2008 & Lancet Oncol 2008). With patients remaining at risk of local relapse for many years, information on long-term outcomes is needed to provide confidence in clinical practice. Here, we report 10-year follow-up of the UK START Trials testing 13- and 15-Fr regimens in terms of local cancer control and late adverse effects. Methods Between 1999 and 2002, 4451 women with completely excised invasive breast cancer (T1-3, N0-1, M0) were randomised after primary surgery to comparisons of 50Gy in 25Fr over 5 weeks vs 41·6Gy or 39Gy in 13Fr over 5 weeks (START A), or 50Gy in 25Fr over 5 weeks vs 40Gy in 15Fr over 3 weeks (START B). Women were eligible if aged over 18 years and did not have an immediate surgical reconstruction. Protocol-specified principal endpoints were local-regional (LR) tumour relapse and late normal tissue effects. Analysis was by intention to treat. Findings Median follow-up in survivors is now 9.3 years in START A and 9.9 years in START B, with 139 LR relapses in START A and 95 in START B. In START A, the 10-year rate of LR relapse was 7.4% (95%CI 5.5–10.0) after 50Gy, 6.3% (95%CI 4.7–8.5) after 41·6Gy and 8.8% (95%CI 6.7–11.4) after 39Gy. In START B, the 10-year rate of LR relapse was 5.5% (95%CI 4.2–7.2) after 50Gy and 4.3% (95%CI 3.2–5.9) after 40Gy. Clinician assessments suggested lower 10-year rates of any moderate/marked late normal tissue effects after 39Gy (43.9%; 95%CI 39.3–48.7) and similar rates after 41.6Gy (49.5%; 95%CI 44.9–54.3) compared with 50Gy (50.4%; 95%CI 45.8–55.3) in START A and lower rates after 40Gy in START B (37.9%; 95%CI 34.5–41.5) compared with 50Gy (45.3%; 95%CI 41.7–49.0). From a planned meta-analysis of START A and the START pilot trial (Owen et al, Lancet Oncol 2006), the adjusted estimate of α/β value for tumour control was 3.5Gy (95% CI 1.2–5.7) and for late change in photographic breast appearance was 3.1Gy (95% CI 2.0–4.2). Interpretation Long-term follow-up confirms that breast cancer and the surrounding dose-limiting healthy tissues respond similarly to radiotherapy fraction size and thus that appropriately-dosed hypofractionated radiotherapy is safe and effective in treatment of patients with early breast cancer. 41·6Gy in 13Fr and 40Gy in 15Fr each appear comparable to 50Gy in 25Fr in terms of local-regional tumour control and late normal tissue effects. These results support the continued use of 40Gy in 15Fr as standard of care (UK NICE Guidance 2009) for women requiring adjuvant radiotherapy for early breast cancer. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr S4-1.

S 71 regions and influences the volume effect.Conclusions: A mechanistic model of normal-tissue damage is an effective framework for summarising the radiobiological knowledgebase of radiation pneumonitis, and plausible parameter values have been derived.Future predictive mechanistic modelling would require more quantitative histopathological studies on relevant local dose effects, thereby providing stronger evidence for the local dose-response relationship.This would provide a stepping stone from which the mechanisms of organ function loss, as a result of 3D distributions of FSU inactivation, could be studied separately.

Introduction: Treatment plan evaluation requires knowledge of the effect of the plan, not only on the intended target, but also the surrounding normal tissues that are unavoidably irradiated. Recent literature has provided estimations of tolerance doses and proposed dose-volume constraints for many of the organs at risk. However, very few of these recommendations have been independently validated. This study details how constraints proposed for the rectum were tested using data from the RT01 randomised prostate radiotherapy trial. Method: An independent validation of the rectal dose-volume constraints used in the CHHiP trial and proposed recently by Fiorino et al. was performed. The constraints were applied retrospectively to the treatment plans collected from the RT01 trial. Odds ratios (OR) were calculated to compare the reported incidence of specific late rectal toxicity end points in the group of patients whose treatment plan met a specified dose-volume constraint compared to the group of patients who failed that constraint. Results: Statistically significant ORs were observed for every constraint tested (except 75 Gy) for at least one clinical end point. For the CHHiP constraints between 60 and 70 Gy, the ORs calculated for rectal bleeding (RMH score defined in protocol) exceeded 2.5 (P!0.02). Similarly the ORs for CHHiP constraints between 30 and 65 Gy exceeded 2.4 (P!0.021) for urgency (UCLA PCI). The Fiorino constraints between 40 and 60 Gy resulted in ORs O2 (P!0.02) for loose stools (UCLA PCI) Conclusion: Implementing rectal dose-volume constraints from 30 Gy up to the prescription dose will result in a decrease in the incidence of late rectal toxicity. Constraints for doses as low as 30 Gy were statistically significant, further challenging the concept that the rectum is a serial structure where the maximum dose to the organ is the only consideration.

FOREWORD The adaptation and integration of imaging into the process of cancer detection, diagnosis, and intervention is an area of medicine that is undergoing extremely rapid development. Radiation therapy is a prime example of this change. The role of the medical physicist in the radiation therapy process accelerates the development and introduction of these technologies into the clinical setting. As a result, imaging is now a pervasive component of radiation therapy with all major imaging modalities represented and numerous examples in which these modalities have been used in treatment planning to allow increased accuracy and precision in the delivery of dose. While the objectives of these developments are clear, they raise numerous issues regarding the skills and resources that assure these technologies are appropriately integrated and applied. Specifically, these developments place enormous pressure on the clinical staff to extend their knowledge base and their scope of responsibility. The IAEA assembled a team of medical physicists with experience in radiation therapy and imaging consisting of: and charged them to examine the increasing role of imaging in the radiation therapy process and make recommendations related to their observations. The current report provides a perspective on the issues related to imaging in radiation therapy assisting the Agency in accommodating these issues in the years ahead.

Évaluer les effets du midazolam sur la consommation d'oxygène (O2) et le niveau de vigilance. Rechercher un ≪effet sédatif≫ propre de la bulle de plexiglas (canopy) du DeltatracTM (Datex) en cas d'administration d'un placebo au lieu de midazolam.étude prospective, comparative, randomisée, en double aveugle, croisée.Huit volontaires sains, de classe physique ASA1, non soumis à un stress, à jeun et au repos.Les sujets ont reçu à TO, par Oie IM, soit du midazolam (0,07 mg·kg−1), soit un placebo, à une semaine d'intervalle, dans un ordre tiré au sort. La O2 a été mesurée à l'aide d'un DeltatracTM, l'état hémodynamique a été surveillé par des méthodes non invasives et le niveau de sedation à l'aide de l'échelle de Ramsay. Les mesures ont été effectuées pendant 195 minutes comme suit: de T30 minutes à TO, puis de T30 minutes à T120 minutes. L'étude statistique a été réalisée par analyse de variance (Anova) pour mesures répétées.La O2 a baissé de façon similaire et significative (P < 0,05) après midazolam et placebo entre TO et T45 minutes et a continué à diminuer uniquement sous midazolam jusquà T60 minutes. Mais, la variation de la O2 entre les deux groupes na pas été significative. Les variables hémodynamiques sont restées identiques dans les deux groupes. Le midazolam a induit un niveau de sedation plus important à T120 minutes.Comme la O2 diminue aussi bien après placebo que sous midazolam, il est conclu que cette diminution pendant les 45 premières minutes est en relation avec la présence de la bulle de plexiglas, en particulier l'isolement acoustique qu'elle procure. Cet≪effet canopy≫ doit être pris en compte lors de mesures de O2 effectuées à l'aide d'une bulle de plexiglas.To assess the effects of midazolam on oxygen consumption (O2) and the level of vigilance. To search for a possible “sedative effect” of the canopy of the DeltatracTM (Datex) when a placebo is administered instead of midazolam.Prospective, comparative, randomized, double-blinded, cross-over study.Eight healthy volunteers of ASA physical class 1, not under stress, fasting and at rest.The volunteers were administered at T0 either midazolam (0.07 mg·kg−1, IM), or a placebo at a one week interval in an order at random. The O2 was measured with a DeltatracTM. Circulatory status was monitored with non invasive methods and the level of vigilance assessed using the Ramsay scale. Statistical analysis was obtained with Anova for repeated measurements with two within factors (drug and time).O2 decreased similarly and significantly between T0 and T45 min (P < 0.05). The decrease continued only after midazolam until T60 min. However the variation of O2 between the midazolam and placebo group was not significant. The haemodynamic variables remained unchanged. Midazolam had a stronger sedative effect at T120 min.As O2 decreased as well after placebo than after midazolam it is concluded that the decrease occurring during the 45 first minutes is related to the presence of the canopy, especially from its acoustic isolation. Such a “canopy effect” should be considered when O2 is assessed with such a device.

To evaluate early and late reactions, local control, disease-free survival, cause-specific survival, and overall survival of elderly breast cancer patients treated with definitive once-a-week hypofractionated radiotherapy together with hormonal therapy.Between 1987 and 1999, 115 patients with a median age of 83 presenting with 124 non-metastatic breast carcinoma were treated with definitive once weekly hypofractionated radiotherapy associated with hormonal therapy. The main reasons for adopting this schedule were patient refusal of surgery, very old age, locally advanced case, and/or comorbid disease. Radiation was delivered as once-a-week, 6.5 Gy for a total breast dose of 32.5 Gy in five fractions, followed with 1–3 fractions of 6.5 Gy to the tumour site. The median follow-up was 41 months.Neoadjuvant hormonal therapy led to 56% reduction of the tumour volume. Late reactions occurred in 46 patients; they were mild to moderate in 87% of these patients. The Kaplan–Meier rate was 52% of patients, with 6% experiencing grade 3 reactions. The 5-year local progression-free rate was 78%. The corresponding cause-specific survival was 71%, and was influenced by T classification, nodal status, oestrogen receptors and the total dose. The first three factors retained an independent prognostic impact on multivariate analysis. The 5-year overall survival was 38%. It was affected by the T classification, lymph node involvement and the performance status (PS). Using a multivariate analysis, only T classification and PS were identified as independent factors regarding overall survival.Definitive hypofractionated radiotherapy allows a good local control, with acceptable toxicity. This schedule associated with hormonal therapy is a good alternative to surgery in non-operable old patients and in case of patient refusal to surgery and to standard fractionation.

Background and purpose: Radiotherapy is the most frequently used treatment for men with localised prostate cancer. Conformal radiotherapy (CFRT) is a relatively new development. MRC RT01 was set-up to explore optimum CFRT dose.Patients and methods: RT01 was an international multi-centre randomised controlled trial for men with T1b-T3a, NO, MO prostate cancer that evolved from a single-centre pilot trial of similar design. All men received at least 3 months of pre-radiotherapy hormone treatment, before randomisation to standard (64 Gy) or high dose (74 Gy) radical CFRT. Accrual was completed in December 2001 with 843 men randomised from 25 centres in less than 4 years. RT01 has been a catalyst for implementing CFRT across UK. In addition to the Trial Management Group, independent Data Monitoring and Ethics Committee and independent Trial Steering Committee, a Quality of Life and Health Economics (QL/HE) group, a radiotherapy Quality Assurance (QA) Group and a Radiography Trial Implementation Group were set up. The QL/HE group ensured implementation, compliance, analysis and interpretation of the QL and HE data in the trial. The inauguration of QA and Radiography groups facilitated inter-centre collaboration. The QA Group ensured procedures were in place before and during trial participation, and monitored quality and consistency with systems including a physics questionnaire, a clinical examples exercise, a standard operating procedure document, designing and building a phantom, and convening a complications modelling subgroup. The Radiography group agreed and implemented technique improvements.Results: More centres participated than initially predicted, enabling recruitment better than scheduled. The trial expedited the implementation of CFRT in many UK radiotherapy centres. Additionally, the QA and Radiography groups helped ensure smooth initiation and established consistency in planning, dosimetry and delivery of prostate CFRT services at participating UK centres.Considerable data has been collected; a series of papers will be produced, although mature clinical trial results are not anticipated until 2006-2008. (C) 2004 Elsevier Ireland Ltd. All rights reserved.

CommentaryUnited Kingdom Radiation Oncology 1 Conference (UKRO 1): Accuracy and uncertainty in radiotherapyB Jones, E Aird, H Colyer, J Dobbs, R Harris, P Hoskin, A Mckenzie and C WestB Jones1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author, E Aird1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author, H Colyer1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author, J Dobbs1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author, R Harris1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author, P Hoskin1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author, A Mckenzie1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this author and C West1Hammersmith Hospital, London, 2Mount Vernon Cancer Centre, Northwood, 3University of Kent, Christ Church, Canterbury, 4St Thomas' Hospital, London, 5The Plymouth Oncology Centre, Plymouth, 6Bristol Oncology Centre, Bristol and 7Patterson Institute, Christie Hospital, Manchester, UKSearch for more papers by this authorPublished Online:28 Jan 2014https://doi.org/10.1259/bjr.75.892.750297SectionsPDF/EPUBFull Text ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail About References 1 Clin Oncol 2001;13(Suppl. 2):S1–S15. 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This paper describes dosimetry measurements performed prior to departments entering patients into the START Trial, a breast fractionation trial, Absolute and relative doses were measured in semi-anatomical breast and chest wall phantoms., as part of a quality assurance programme visit. Doses were measured using an ionization chamber and the resulting distributions were compared with those calculated by the department. The mean ratio of measured to calculated dose at the START reference point was found to be 0.981 for the breast phantom and 0.978 for the chest wall phantom. This average measured dose was significantly less than the prescribed dose (p < 0.001). Differences were found between 2D and 3D planning systems and for departments using cobalt 60 beams. A number of departments had deviations of greater than 4%, which was the tolerance applied for this trial. It is essential for dose measurements of this type to be performed for randomized clinical trials involving radiotherapy, particularly where dose fractionation regimes are being compared.