This trial is active, not recruiting.

Conditions rectal neoplasm, neoadjuvant therapy
Treatment capecitabine, irinotecan
Phase phase 2
Sponsor National Cancer Center, Korea
Start date July 2004
End date December 2008
Trial size 48 participants
Trial identifier NCT00506623, NCCCTS 04-088


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Pathologic stage Tumor regression grade
time frame: After operation

Secondary Outcomes

time frame: During chemoradiation

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
Principal investigator Kyung Hae Jung, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2007.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.