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

PHASE3UnknownINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

November 30, 2017

Study Completion Date

December 31, 2017

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

Trial Locations (1)

Unknown

University Hospital of Crete, Dep of Medical Oncology, Heraklion

All Listed Sponsors
collaborator

University Hospital of Crete

OTHER

lead

Hellenic Oncology Research Group

OTHER