Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00807911
First received: December 11, 2008
Last updated: February 3, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: Adjuvant FL Drug: Adjuvant FOLFOX |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Study of Adjuvant Chemotherapy With 5-FU/Leucovorin vs. Oxaliplatin/5-FU/Leucovorin After Preoperative Chemoradiotherapy With Fluoropyrimidines Followed by Surgery in Patients With Locally Advanced Rectal Cancer |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- disease-free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival, pattern of failure,safety, quality of life [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 320 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Adjuvant FL
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
|
Drug: Adjuvant FL
5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
|
Experimental: Adjuvant FOLFOX
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
|
Drug: Adjuvant FOLFOX
oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
Detailed Description:
Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the rectum
- Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
- AJCC/UICC pathologic stages of ypT3-4 or ypN+
- Curative surgery not less than 3 and not more than 8 weeks prior to randomization
- No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
- ECOG PS 0-1
- Adequate organ function
- Informed Consent
Exclusion Criteria:
- Macroscopic or microscopic evidence of remaining tumor
- Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- More than 8 weeks after curative surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807911
Locations
| Korea, Republic of | |
| National Cancer Center | |
| Goyang, Korea, Republic of | |
| Seoul National Unversity Bundang Hospital | |
| Seongnam, Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of | |
| Yeonsei University Hosptial | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Asan Medical Center
Investigators
| Principal Investigator: | Tae Won Kim, Professor | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Tae Won Kim, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00807911 History of Changes |
| Other Study ID Numbers: | AMC-0256 |
| Study First Received: | December 11, 2008 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
|
rectal cancer adjuvant chemotherapy FOLFOX |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic Leucovorin |
Levoleucovorin Oxaliplatin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013