Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Study Overview
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Brief Summary
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This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer

Detailed Description
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This study is an open-label, single center, nonrandomized phase II study. Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor were delivered concurrently with chemotherapy. Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 & 29). Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed. Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks.

Official Title
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A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.

Conditions
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Rectal Neoplasm, Neoadjuvant Therapy

Intervention / Treatment
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* Drug: Capecitabine, Irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the rectum Distal margin of tumor located from 0 to 8 cm from anal verge Tumor must be clinically resectable by surgery and R0 resection must be most likely ECOG performance status 0-2 No prior chemotherapy, radiotherapy to pelvis, and immunotherapy Adequate organ functions Patients must sign an informed consent Exclusion Criteria: Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease Any unresected synchronous colon cancer Any distant metastasis Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix Any other morbidity or situation with contraindication for chemoradiotherapy Patients have history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine Pregnant or lactating women or patients of childbearing potential not practicing adequate contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine, Irinotecan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic stage Tumor regression grade |  | After operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | During chemoradiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal neoplasm, Neoadjuvant therapy, Radiotherapy, Combination chemotherapy, Irinotecan, Capecitabine