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IRCT20211108052999N1 IRCT 2021-11-25 Tehran University of Medical Sciences Comparison of pathologic response & safety in standard neoadjuvant therapy versus concomitant boost radiotherapy in patient with localy advanced rectal cancer. Comparison of pathologic response & safety in standard neoadjuvant therapy versus concomitant boost radiotherapy in patient with localy advanced rectal cancer reffered to cancer institute from 2021 to 2024. 2021-11-22 anticipated 100 Complete https://irct.ir/trial/59870 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, block randomization list created by sealed envelope website in two group with 4, 6, 8 block size. 2 Rectal cancer. Intervention 1: Intervention group: In intervention group, the chemotherapy regimen is similar to the first group, and in radiotherapy, in addition to 4500 cGy per pelvis, the patient receives 1100 cGy dose of concomitant boost (220 cGy on the sixth sixth day of each week). The following complications are evaluated weekly according to the CTC-AE NCI VERSION 4.0 guideline: Rectitis Diarrhea Dermatitis Hematologic complications Post-op complications for one month after surgery including wound problems, abscesses, ostomy problems, . Intervention 2: Control group: in this group standard treatment including two-phase radiotherapy with a dose of 4500 cGy to pelvis and 540 cGy dose of boost to GTV and nodes involved and concomitant chemotherapy with capcitabine at a dose of 825 mg / m² / bd on radiotherapy days and after 12-10 weeks. And surgery. Between chemoradiotherapy and surgery, patients undergoing chemotherapy (every three weeks) are on the following regimen: xelox (capecitabine 1000 mg / m², oxaliplatin 130 mg / m²). Reassessment is performed immediately before surgery by pelvic MRI. Chemotherapy is continued with the Xelox diet. The total duration of chemotherapy before and after surgery is six months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan for releasing…
public Mehdi Aghili
Imam Khomeini hospital complexm, Keshavarz boulevard
TeHran Iran (Islamic Republic of) 1419733141 +98 21 6119 2585 aghili@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mehdi Aghili
Imam Khomeini hospital complexm, Keshavarz boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2585 aghili@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Good performance (kps> 70) T3,T4 N0 in 12 of anal verge Node+ T2N0 in 5 cm of anal verge No metastasis no limit no limit Both Incomplete chemotherapy or radiotherapy Recurrence Chemotherapy before radiotherapy Metastasis C20 Malignant neoplasm of rectum Treatment - Other Treatment - Other Intervention group: In intervention group, the chemotherapy regimen is similar to the first group, and in radiotherapy, in addition to 4500 cGy per pelvis, the patient receives 1100 cGy dose of concomitant boost (220 cGy on the sixth sixth day of each week). The following complications are evaluated weekly according to the CTC-AE NCI VERSION 4.0 guideline: Rectitis Diarrhea Dermatitis Hematologic complications Post-op complications for one month after surgery including wound problems, abscesses, ostomy problems, ... Control group: in this group standard treatment including two-phase radiotherapy with a dose of 4500 cGy to pelvis and 540 cGy dose of boost to GTV and nodes involved and concomitant chemotherapy with capcitabine at a dose of 825 mg / m² / bd on radiotherapy days and after 12-10 weeks. And surgery. Between chemoradiotherapy and surgery, patients undergoing chemotherapy (every three weeks) are on the following regimen: xelox (capecitabine 1000 mg / m², oxaliplatin 130 mg / m²). Reassessment is performed immediately before surgery by pelvic MRI. Chemotherapy is continued with the Xelox diet. The total duration of chemotherapy before and after surgery is six months. Pathologic response. Timepoint: After surgery. Method of measurement: Tissue pathological assesment. Treatment adverse effect. Timepoint: Weekly during treatment. Method of measurement: Examination, CBC and renal function test. Clinical response. Timepoint: Before intervention and before surgery. Method of measurement: MRI. Tehran University of Medical Sciences Approved 2021-11-02 Imam Khomeini hospital Ethics Committee of research Imam Khomeini hospital complex, Tehran University of Medical Science (ethics committee) Tehran Tehran Iran (Islamic Republic of)