Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles

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Fudan University

Status and phase

Completed
Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy
Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00868816
2009-02

Details and patient eligibility

About

The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

Full description

We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Enrollment

400 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age < 75 years with histologically proven adenocarcinoma of the colon or rectum
  • no severe major organ dysfunction
  • WHO performance status of 0 or 1
  • Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)

Exclusion criteria

  • age >= 75
  • severe major organ dysfunction
  • WHO performance status of >1
  • Stage I or Stage IV

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

1
Experimental group
Description:
12 cycles of oxaliplatine based adjuvant chemotherapy
Treatment:
Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy
2
Active Comparator group
Description:
8 cycles of oxaliplatine based adjuvant chemotherapy
Treatment:
Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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