Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

June 1, 2015

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2027

Conditions
Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Interventions
RADIATION

Radiotherapy 50 Gy

Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks

DRUG

Fluorouracil/folic acid

Fluorouracil 400 mg/m² D1-4 and folic acid 20mg/m2 D1-4 the first and fifth weeks of radiotherapy

DRUG

Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)

oxaliplatin: 85 mg/m² in 2 hours at D1; folinic acid: 100 mg/m² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg/m² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg/m² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).

RADIATION

Radiotherapy 50 Gy

"Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session; 25 fractions) + fluorouracil/leucovorin 400 mg/m² 1-4 day the first and fifth weeks of radiotherapy.~FOLOFX4 will be administrated for 8 cycles over a 16 week period. Patients will undergo re-staging within 6 weeks of their 8th cycle of FOLFOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 8 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous fluorouracil."

Trial Locations (1)

45304

RECRUITING

Rita Ambraziene, Kaunas

All Listed Sponsors
lead

Lithuanian University of Health Sciences

OTHER