ClinicalTrials.Veeva

Menu

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

Samsung Medical Center logo

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

Trial contacts and locations

17

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems