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IRCT20251017067655N1 IRCT 2025-12-28 Babol University of Medical Sciences Evaluation of the effect of total neoadjuvant therapy in rectal cancer Comparison of pathological response rates in long-term chemoradiotherapy versus short-term radiotherapy in the total neoadjuvant treatment of patients with locally advanced rectal cancer in the context of a randomized clinical trial 2025-10-16 anticipated 60 Complete https://irct.ir/trial/88313 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a blocked randomization method with double and quadruple permutations will be used to allocate patients to the two groups. In this method, two- and four-patient blocks, each comprising combinations of the two treatment arms, are created. To prevent predictability of future treatment assignments, the order of the blocks is determined using a random number table. Accordingly, for a sample size of 60 patients, ten four-patient blocks will be selected from the combinations AABB, ABAB, ABBA, BABA, BBAA, and BAAB, and ten two-patient blocks will be selected from the combinations AB and BA, using a random number table. 1-2 Rectal Cancer. Intervention 1: Intervention group: patients initially receive neoadjuvant induction chemotherapy consisting of one of the following regimens—FOLFOX-4, mFOLFOX-6, or CapOx—for 3 to 4 cycles, according to the treating physician’s discretion.In Group A, 11–18 days after completion of induction chemotherapy, patients undergo long-course chemoradiotherapy, consisting of radiotherapy to a total dose of 50–50.4 Gy delivered in 25–28 daily fractions, with concurrent oral capecitabine at a dose of 825 mg/m² on radiotherapy days. Subsequently, after an interval of 11–18 days, patients receive consolidation chemotherapy using the same regimens.After completion of total neoadjuvant therapy, patients undergo total mesorectal excision (TME) 2–4 weeks after the final cycle of chemotherapy. Abdominoperineal resection (APR) is performed for low rectal tumors, and low anterior resection (LAR) for mid and upper rectal tumors.The clinical target volume (CTV) for radiotherapy includes the primary tumor, the entire mesorectum, and regional lymph nodes in accordance with RTOG guidelines. Radiotherapy boost to the primary tumor with a 1-cm margin may be delivered at the treating physician’s discretion. Intervention 2: Intervention group: patients initially receive neoadjuvant induction chemotherapy consisting of one of the following regimens—FOLFOX-4, mFOLFOX-6, or CapOx—for 3 to 4 cycles, according to the treating physician’s discretion.In Group B, following induction chemotherapy, patients receive short-course radiotherapy consisting of 5 Gy per fraction for 5 fractions over 5 days (maximum 8 days). After an interval of 11–18 days, consolidation chemotherapy with either a FOLFOX-based regimen or CapOx is administered.After completion of total neoadjuvant therapy, patients undergo total mesorectal excision (TME) 2–4 weeks after the final cycle of chemotherapy. Abdominoperineal resection (APR) is performed for low rectal tumors, and low anterior resection (LAR) for mid and upper rectal tumors.The clinical target volume (CTV) for radiotherapy includes the primary tumor, the entire mesorectum, and regional lymph nodes in accordance with RTOG guidelines. Radiotherapy boost to the primary tumor with a 1-cm margin may be delivered at the treating physician’s discretion. Yes - There is a plan to make this available What will be shared: In this study, anonymized raw and processed data will be collected, including patient demographic characteristics, tumor features, details of neoadjuvant treatment (chemotherapy and radiotherapy), surgical findings, pathological outcomes (including pathological complete response), and treatment-related outcomes and toxicities. In addition, the study protocol, data collection forms, and final statistical analysis reports will be available for sharing. After completion of the study and publication of the results, de-identified data will be shared exclusively for research purposes upon formal request and approval by the principal investigator. Data sharing will be conducted in compliance with ethical standards, patient confidentiality, and non-commercial use policies. When: Start of access period: 6 months after publication of the results To whom: Researchers affiliated with academic and scientific institutions Conditions: The data and documents generated in this study will be available solely for scientific research purposes, including secondary analyses, systematic reviews, and meta-analyses, with the aim of advancing scientific knowledge in the field of rectal cancer treatment. Access to the data will be granted upon formal request and approval by the principal investigator, subject to compliance with research ethics principles, protection of patient confidentiality, and complete anonymization of participant information. The data may be used exclusively for non-commercial and academic research purposes. Where to obtain: shabnam Ashofte 09353413556 How to obtain: All requests for access to the study data or documents must be submitted in writing to the principal investigator. Upon receipt, the principal investigator will review and evaluate the request, and if approved, access to the data will be provided in anonymized files, in compliance with confidentiality and research ethics principles. All use of the data is strictly limited to research and non-commercial purposes, and recipients are required to adhere to the terms of use and not disclose any identifiable patient information.” Comments:
public Shabnam AshofteBargi
Shilat Sq , shariati Blvd, shahid rajaee hospital
Babolsar Iran (Islamic Republic of) 4741999874 +98 11 3525 2730 shabnam.ir@gmail.com Babol University of Medical Sciences scientific Shabnam AshofteBargi
Shilat Sq , shariati Blvd, shahid rajaee hospital
Babolsar Iran (Islamic Republic of) 4741999874 +98 11 3525 2730 shabnam.ir@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Histopathologic confirmation of rectal adenocarcinoma Clinical stage cT3–T4 and/or presence of MRI-defined positive lymph nodes ECOG performance status of 0–2 Adequate bone marrow function (hemoglobin > 10 g/dL; white blood cell count > 3 × 10⁹/L; absolute neutrophil count > 1.5 × 10⁹/L; platelet count > 100 × 10⁹/L Adequate hepatic function (SGOT and/or SGPT ≤ 3 × the upper limit of normal) Adequate renal function (serum creatinine < 1.6 mg/dL) 18 years no limit Both Refusal to provide informed consent for study participation Synchronous adenocarcinoma in other segments of the colon Presence of distant metastasis at initial diagnosis History of prior malignancy, except for basal cell carcinoma (BCC) of the skin History of prior chemotherapy History of prior pelvic radiotherapy Inflammatory bowel disease Bilateral hip prostheses C20 Malignant neoplasm of rectum Treatment - Other Treatment - Other Intervention group: patients initially receive neoadjuvant induction chemotherapy consisting of one of the following regimens—FOLFOX-4, mFOLFOX-6, or CapOx—for 3 to 4 cycles, according to the treating physician’s discretion.In Group A, 11–18 days after completion of induction chemotherapy, patients undergo long-course chemoradiotherapy, consisting of radiotherapy to a total dose of 50–50.4 Gy delivered in 25–28 daily fractions, with concurrent oral capecitabine at a dose of 825 mg/m² on radiotherapy days. Subsequently, after an interval of 11–18 days, patients receive consolidation chemotherapy using the same regimens.After completion of total neoadjuvant therapy, patients undergo total mesorectal excision (TME) 2–4 weeks after the final cycle of chemotherapy. Abdominoperineal resection (APR) is performed for low rectal tumors, and low anterior resection (LAR) for mid and upper rectal tumors.The clinical target volume (CTV) for radiotherapy includes the primary tumor, the entire mesorectum, and regional lymph nodes in accordance with RTOG guidelines. Radiotherapy boost to the primary tumor with a 1-cm margin may be delivered at the treating physician’s discretion. Intervention group: patients initially receive neoadjuvant induction chemotherapy consisting of one of the following regimens—FOLFOX-4, mFOLFOX-6, or CapOx—for 3 to 4 cycles, according to the treating physician’s discretion.In Group B, following induction chemotherapy, patients receive short-course radiotherapy consisting of 5 Gy per fraction for 5 fractions over 5 days (maximum 8 days). After an interval of 11–18 days, consolidation chemotherapy with either a FOLFOX-based regimen or CapOx is administered.After completion of total neoadjuvant therapy, patients undergo total mesorectal excision (TME) 2–4 weeks after the final cycle of chemotherapy. Abdominoperineal resection (APR) is performed for low rectal tumors, and low anterior resection (LAR) for mid and upper rectal tumors.The clinical target volume (CTV) for radiotherapy includes the primary tumor, the entire mesorectum, and regional lymph nodes in accordance with RTOG guidelines. Radiotherapy boost to the primary tumor with a 1-cm margin may be delivered at the treating physician’s discretion. Pathologic complete response (pCR): The proportion of patients with no viable tumor cells in the resected rectum and regional lymph nodes following total neoadjuvant therapy and surgery. Timepoint: end of treatment at the time of surgery. Method of measurement: Histopathological evaluation of surgical specimens (TME: APR or LAR) by an experienced pathologist. Acute treatment-related toxicities: Including anemia, neutropenia, thrombocytopenia, diarrhea, nausea/vomiting, anorexia, dysuria, and other adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Timepoint: Weekly clinical and laboratory evaluation during radiotherapy and every 2–3 weeks during chemotherapy. Method of measurement: CBC, medical history and physical exam. Babol University of Medical Sciences Approved 2025-10-15 Ethics committee of babol University of Medical Sciences ganj afruz Ave, babol university of medical science babo Mazandaran Iran (Islamic Republic of)