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IRCT20250702066338N1 IRCT 2025-12-13 Shiraz University of Medical Sciences To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer A phase II clinical trial 2026-01-21 anticipated 33 Complete https://irct.ir/trial/84589 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients were randomly selected from the hospital admission department with odd numbers in the admission office as the control group and even numbers in the admission office as the intervention group. They were numbered based on a random number table and named control and intervention groups using lowercase English letters. 2 Rectal cancer. Intervention 1: Intervention group: Short-course radiotherapy will be administered in 5 fractions, delivering 5 Gy per day to the gross tumor and regional lymph nodes (total dose: 25 Gy over 5 consecutive days). A Simultaneous Integrated Boost (SIB) will be applied, delivering an additional 5 Gy in 5 fractions (1 Gy per fraction) to the GTV, without increasing the total number of treatment sessions. Intervention 2: "Control group": Short-term radiation therapy: 5 fractions, 5 Gy given each day to the entire tumor and lymph nodes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is .
public Mohammad mohamadianpanah
Namazi hospital, Molasadra St
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5000 mohpanah@gmail.com Shiraz University of Medical Sciences scientific Mohammad mohamadianpanah
Namazi hospital, Molasadra St
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5000 mohpanah@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The patient with stage II and III rectal cancer Diagnosis confirmed by biopsy and pathology assessment Tumor range is 15 cm from anus ECOG= 0-2 Renal and liver and bone marrow with normal function no limit no limit Both Distant metastasis at presentation Past history of radiation or surgery in pelvis for rectal cancer The patient with comorbidity Patient's dissatisfaction to participate in the trial C20 Malignant neoplasm of rectum Treatment - Other Treatment - Other Intervention group: Short-course radiotherapy will be administered in 5 fractions, delivering 5 Gy per day to the gross tumor and regional lymph nodes (total dose: 25 Gy over 5 consecutive days). A Simultaneous Integrated Boost (SIB) will be applied, delivering an additional 5 Gy in 5 fractions (1 Gy per fraction) to the GTV, without increasing the total number of treatment sessions. "Control group": Short-term radiation therapy: 5 fractions, 5 Gy given each day to the entire tumor and lymph nodes. Pathologic complete response ratio. Timepoint: 8 weeks after radiotherapy. Method of measurement: Biopsy and pathology assessment. Incidence of adverse events. Timepoint: Every week in radiotherapy course then every 3 months for 2 years. Method of measurement: History and physical examination. Shiraz University of Medical Sciences Approved 2025-06-23 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)