A Randomized, Multicenter, Phase III Study to Compare 6 Months of either 5-Fluorouracil / l-leucovorin plus Oxaliplatin (mFOLFOX6) or Capecitabine plus Oxaliplatin (XELOX) with 3 Months of either mFOLFOX6 or XELOX as Adjuvant Chemotherapy in Patients with Completely Resected Stage III Colon Cancer
- Conditions
- stage III colon cancer (including rectosigmoid cancer)
- Registration Number
- JPRN-UMIN000008543
- Lead Sponsor
- Japanese Foundation for Multidisciplinary Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 1200
(1) Histologically confirmed adenocarcinoma of the colon.
(2) Predominantly located in the cecum, colon, or rectosigmoid region based on the findings from surgery and/or surgical specimen.
(3) D2 or D3 lymph nodes resection.
(4) Curability A surgery (no residual tumor visible to macroscopically and/or microscopically).
(5) Stage III (T any N1/2/3 M0) (cf. The Japanese Classification of Colorectal Carcinoma, 7th edition, revised version).
(6) Registration within 8 weeks after resection and chemotherapy starting within 2 weeks after registration.
(7) Age >= 20 years.
(8) ECOG performance status of 0-1.
(9) Body surface area (DuBois) <=2.2 m2.
(10) No prior chemotherapy, immunotherapy, or radiation therapy.
(11) Adequate organ function:
i) neutrophil count >=1,500/mm3
ii) platelet count >=100,000/mm3
iii) serum creatinine <=1.5 times the ULN
iv) CCr >=30mL/min
v) total bilirubin <=2.0 mg/dL
vi) AST and ALT <=100 IU/L
vii) CEA <=10 ng/mL
(12) Written informed consent.
(1) Cancer of the appendix.
(2) Past history of malignancy. (When there is the unrecurred period of 5 or more years, the intramucosal carcinoma [stomach cancer, colorectal cancer, esophagus cancer] by which recovery excision was performed endoscopically, the uterine cervical cancer, the basal cell carcinoma of the skin, and squamous cell carcinoma of the skin by which curative excision was performed can be enrolled.)
(3) Women who are pregnant or breast-feeding.
(4) Women who may become pregnant and fertile men.
(5) Participation in another clinical trial within 30 days before registration.
(6) Existing grade 1 or more peripheral sensory neuropathy.
(7) Uncontrolled diabetes mellitus (including insulin therapy).
(8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and/or arrhythmia.
(9) Continuous systemic steroid therapy (oral or intravenous administration).
(10) A history and/or current evidence of significant neurological and/or mental illness.
(11) Active infectious disease (including known active hepatitis B virus infection, hepatitis C virus infection and human immunodeficiency virus).
(12) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
(13) A history of allergy to 5-FU, l-LV, oxaliplatin, and/or capecitabine.
(14) Prior chemotherapy including oxaliplatin.
(15) Other reasons for being unfit for the study as determined by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival*1 <br>*1: DFS is defined as relapse or death by IDEA.
- Secondary Outcome Measures
Name Time Method (1) Disease-free survival*2 <br>*2: DFS is defined as relapse, second cancer or death.<br>(2) Time to treatment failure <br>(3) Overall survival <br>(4) Adverse events <br>(5) Completion rate <br>(6) Relative dose intensity <br>(7) Peripheral neuropathy <br>(8) Lymph node metastasis, lymph node dissection, lymph nodes examined, and prognosis <br>(9) Exploration of prognostic indicators and adverse events <br>(Additional study: Pharmacogenomics).