Background: At present, distant metastasis remains the main cause of failure for locally advanced rectal cancer (LARC), efficient short-course radiotherapy (SCRT) combined with neoadjuvant chemotherapy is an attempt of optimizing pre-operative treatment. Methods: We did this randomized, phase III study in multiple centers in China. Patients with middle or lower rectal adenocarcinomas, staged cT3-4 and/or N1-2 by MRI, were randomly assigned to receive 5Gy × 5 and 4 courses of CAPOX (experimental group) or 50 Gy in 25 fractions concurrently with capecitabine (control group). TME in both groups was performed 6-8 weeks later, then two or six courses of CAPOX as postoperative chemotherapy was prescribed in experimental or control group, respectively. The purpose of this interim analysis was focusing on the compararison of primary enrolled 100 patients. Results: Initially enrolled 100 patients, 51 in experimental group and 49 in control group were analyzed, with MRF+ 27.5% vs. 30.6%, MRI based T3-4 92.2% vs. 98.0%, N1-2 74.5% vs. 77.6%, and EMVI scores3-4 52.9% vs. 65.3% in each group. The completion rates of neoadjuvant treatment were 98.0% vs. 100% (p = 0.325), with incidences of grade III-IV toxicity 17.6% vs. 4.1% (p = 0.076) in each group, respectively. 80 patients completed surgery and 7 patients (all in experimental group) chose "watch-and-wait" policy due to clinical complete remission (cCR) after neoadjuvant treatment. 92.9% and 89.5% of patients in experimental and control group had R0 resection (p = 0.593), while 26.2% and 5.3% of them achieved ypT0N0 (p = 0.011), respectively. The completion rates of adjuvant chemotherapy were 76.2% vs. 65.8% (p = 0.305) in each group, respectively. On the whole, the patients who had received 6 cycles of chemotherapy accounted for 62.7% vs. 49.0% (p = 0.000) in experimental and control group, and there were 76.5% and 49.0% of patients who could complete all planned treatments in each group, respectively. Conclusions: The interim analysis revealed the acute toxicity and surgical complication were acceptable and comparable in both groups, however, the people in experimental group showed better treatment completion. Clinical trial identification: NCT02533271. Legal entity responsible for the study: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College. Funding: Collaborative Innovation Center for Cancer Medicine [No. XT2015-03]. Disclosure: All authors have declared no conflicts of interest.

To evaluate the safety and efficacy of adjuvant intensity modulated radiation therapy (IMRT) with concurrent paclitaxel and cisplatin (TP) in early-stage cervical cancer patients with high risk factors after radical hysterectomy. Patients who underwent radical hysterectomy for International Federation of Gynecology and Obstetrics stage IB – IIA cervical cancer and had high risk factors for recurrence were recruited. One cycle of TP was delivered before and after concurrent chemoradiation therapy, respectively. Concurrent chemoradiation therapy began 21 days after the start of the initial cycle of the chemotherapy, with 2 cycles of TP delivered on day 1 and day 29 of radiation therapy. Primary endpoints were overall survival (OS) and relapse-free survival (RFS), with toxicities, local-regional control (LC), and distant failure (DF) rate as secondary endpoints. Between 2008 and 2012, 68 patients were evaluable. The 2-year and 4-year RFS rates were 98.2% and 91.2%, respectively. Corresponding OS rates were 98.1%, and 94.6%, respectively. The 4-year LC and DF rates were 98.5% and 4.4%, respectively. Grade 3 to 4 acute leucopenia, neutropenia, and thrombocytopenia occurred in 25.0%, 11.8%, and 1.5% of patients, respectively. Of evaluable patients, 89.7% and 60.3% experienced acute vomiting and diarrhea, but only 5.9% and 5.9% patients were grade 3, respectively. No case of chronic toxicity exceeded grade 2. Adjuvant concurrent IMRT with paclitaxel plus cisplatin are safe and effective in early-stage cervical cancer patients with high risk factors for recurrence following radical hysterectomy.