Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT00506623

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasm Neoadjuvant Therapy	Drug: Capecitabine, Irinotecan	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2004

Anticipated Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Pathologic stage Tumor regression grade [After operation]

Secondary Outcome Measures

Toxicity [During chemoradiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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