Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer

Summary

The purpose of this study is to compare whether a 3-month treatment is at least not inferior to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of RFS in patients with high risk stage II or stage III radically resected colon cancer.

Conditions

• CRC

Interventions

DRUG

5-Fluorouracil

5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 \& 2, q2w, for 12 cycles

DRUG

Leucovorin

Leucovorin 200mg/m2 IV in 2 hours, days 1 \& 2, q2w, for 12 cycles

DRUG

Oxaliplatin

Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles

DRUG

Capecitabine

Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles

DRUG

5-Fluorouracil

5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 \& 2, q2w, for 6 cycles

DRUG

Leucovorin

Leucovorin 200mg/m2 IV in 2 hours, days 1 \& 2, q2w, for 6 cycles

DRUG

Capecitabine

Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 4 cycles

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles

DRUG

Oxaliplatin

Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles

Sponsors & Collaborators

• University Hospital of Crete

  collaborator OTHER

• Hellenic Oncology Research Group

  lead OTHER

Principal Investigators

• John Souglakos, MD · University Hospital of Crete, Dep of Medical Oncology

• Vassilis Georgoulias, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2017-11-30

Completion

2017-12-31

Countries

• Greece

Study Locations