Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Phase 2

• Conditions: Rectal Neoplasm; Neoadjuvant Therapy

• Registration Number: NCT00506623
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-07
• Status Verified: 2007-07
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Last Update Submitted: 2007-07-23
• Study First Posted: 2007-07-25
• Last Update Posted: 2007-07-25
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathologic stage Tumor regression grade	After operation

Secondary Outcome Measures

Name	Time	Method
Toxicity	During chemoradiation

Trial Locations

Locations (1)

National Cancer Center Korea; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of