Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

ConditionNeoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorLithuanian University of Health Sciences

About this trial

Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with rectal adenocarcinoma;

radiologically measurable tumor size;

general condition (ECOG 0-2 points);

stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),

Disqualifiers

patients with signs of intestinal obstruction at the start of treatment;

previous lower abdominal radiation therapy;

other tumors over a five-year period;

pregnant or breastfeeding women;

Trial design

Design model

Parallel

Treatments tested in this trial

Radiotherapy 50 Gy
Radiation
Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks
Fluorouracil/folic acid
Drug
Fluorouracil 400 mg/m² D1-4 and folic acid 20mg/m2 D1-4 the first and fifth weeks of radiotherapy
Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)
Drug
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).
Radiotherapy 50 Gy
Radiation
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.

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Arm A (Control): Radiotherapy + fluorouracilActive comparator 2 interventions

Group B: Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimenExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

disease-free survival

To compare the 3-year disease-free survival between the investigational arm and the control arm.

Time frame

3 year

Secondary outcomes

Overall survival

Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.

Time frame

7 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lithuanian University of Health Sciences

Lead sponsor

Source ClinicalTrials.gov

Apply now