Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

818

Participants

Timeline

Start Date

September 30, 2020

Primary Completion Date

August 31, 2030

Study Completion Date

August 31, 2030

Conditions
Rectal Cancer
Interventions
DRUG

mFOLFOX (neoadjuvant)

neoadjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered.

DRUG

XELOX (neoadjuvant)

neoadjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered.

DRUG

mFOLFOX (adjuvant)

adjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered.

DRUG

XELOX (adjuvant)

adjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered.

DRUG

Capecitabine (adjuvant)

adjuvant application Capecitabine: 1,250 mg/m2 bid, po, on days 1-14 Cycles are repeated on day 22. A total of 8 cycles are administered.

DRUG

"infusional 5-FU/FA AIO regimen (adjuvant)"

adjuvant application Folinic acid 2h i.v. 500 mg/m² 5-FU 2,600mg/m² (24h infusion) Days 1, 8, 15, 22, 29, 36; cycle is repeated day 57 (representing one cycle); a total of 3 cycles should be administered.

DRUG

"infusional 5-FU/FA de Gramont (adjuvant)"

adjuvant application Folinic acid 2h i.v. 200 mg/m² days 1 and 2 5-FU 400mg/m² bolus followed by 600mg/m² 22h infusion days 1 and 2 The cycle is repeated day 15; a total of 12 cycles should be administered.

Trial Locations (1)

68167

RECRUITING

Unversity Hospital Mannheim, Mannheim

All Listed Sponsors
collaborator

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

collaborator

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

collaborator

German Rectal Cancer Study Group

UNKNOWN

lead

Ralf Hofheinz

OTHER

NCT04495088 - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter