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Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center Identifier:
First received: December 11, 2008
Last updated: January 11, 2016
Last verified: January 2016
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
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 Tae Won Kim, Asan Medical Center:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 3 year ]

Secondary Outcome Measures:
  • overall survival, pattern of failure,safety, quality of life [ Time Frame: 3 year ]

Estimated Enrollment: 320
Study Start Date: November 2008
Estimated Study Completion Date: December 2016
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00807911

Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of
Seoul National Unversity Bundang Hospital
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Yeonsei University Hosptial
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Tae Won Kim, Professor Asan Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tae Won Kim, Professor, Asan Medical Center Identifier: NCT00807911     History of Changes
Other Study ID Numbers: AMC-0256
Study First Received: December 11, 2008
Last Updated: January 11, 2016

Keywords provided by Tae Won Kim, Asan Medical Center:
rectal cancer
adjuvant chemotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents processed this record on May 25, 2017