Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Colon Cancer

Treatments: Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01092481

2009-11-008 (Other Identifier)

Details and patient eligibility

About

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.

Full description

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.

Enrollment: 1,580 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Curatively resected, histologically confirmed colon adenocarcinoma
• AJCC/UICC high-risk stage II, stage III colon cancer
• Age over 18 years old
• Performance status (ECOG scale): 0-1
• Adequate major organ functions
• Patients should sign a written informed consent before study entry

Exclusion criteria

• Colon cancer other than adenocarcinoma
• Rectal cancer
• R1 or R2 resections
• Other malignancies within the last 5 years
• Symptomatic peripheral sensory neuropathy
• Presence of other serious disease
• Lactating or pregnant women
• Fertile women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,580 participants in 2 patient groups

FOLFOX_12 or CAPOX_8

Active Comparator group

Description:

6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX

Treatment:

Drug: oxaliplatin

FOLFOX_6 or CAPOX_4

Experimental group

Description:

3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX

Treatment:

Drug: oxaliplatin