- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506623
Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer
A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Gyeonggi
-
Goyang, Gyeonggi, Korea, Republic of, 410-769
- National Cancer Center Korea
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathologic stage Tumor regression grade
Time Frame: After operation
|
After operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: During chemoradiation
|
During chemoradiation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyung Hae Jung, M.D.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Irinotecan
Other Study ID Numbers
- NCCCTS 04-088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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