Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00807911
First received: December 11, 2008
Last updated: July 17, 2014
Last verified: July 2014
  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: July 2014 (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:

  1. Histologically confirmed adenocarcinoma of the rectum
  2. Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
  3. AJCC/UICC pathologic stages of ypT3-4 or ypN+
  4. Curative surgery not less than 3 and not more than 8 weeks prior to randomization
  5. No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
  6. ECOG PS 0-1
  7. Adequate organ function
  8. Informed Consent

Exclusion Criteria:

  1. Macroscopic or microscopic evidence of remaining tumor
  2. Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
  3. More than 8 weeks after curative surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 17, 2014
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
Leucovorin
Levoleucovorin
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014