Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer (RECTUM2015)

Lithuanian University of Health Sciences

Status and phase: Enrolling; Phase 2

Conditions: Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

Treatments: Radiation: Radiotherapy 50 Gy; Drug: Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4); Drug: Fluorouracil/folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05378919

RECTUM2015

Details and patient eligibility

About

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

Full description

This is a biomedical research, phase II, multicenter, open-label, randomized study, comparing neoadjuvant CT with FOLFOX4, versus immediate preoperative chemoradiotherapy (CRT), in patients with locally advanced rectal cancer. Randomization in a 1: 1 ratio, neoadjuvant chemotherapy or chemoradiation. The purpose of the study is to evaluate the efficacy, tolerability, and comparability of new standard preoperative chemotherapy with FOLFOX4 in patients with stage II and III colorectal cancer compared to routine chemoradiation.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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),
• in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));
• during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;
• Blood tests 28 days before the start of treatment:

and general blood count: neutrophils greater than 1.5x10 9 / l, platelets greater than 100 x 10 9 / l, Hemoglobin greater than 80 g / l, liver enzymes (Aspartate aminotransferase (AST/GOT), alanine aminotransferase (ALT/GPT) not more than 3 times upper limit), and renal function (creatinine up to 1.5 times the upper limit of normal) is normal; women of childbearing potential - negative pregnancy test;

• A signed informed consent form.

Exclusion criteria

• 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;
• men and women of childbearing potential who do not agree to use adequate contraception;
• Patient co-morbidities that would make the patient unsuitable for this study or significantly interfere with the assessment of safety and toxicity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Arm A (Control): Radiotherapy + fluorouracil

Active Comparator group

Description:

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) , then 6-8 weeks after chemoradiation, surgery, followed by adjuvant chemotherapy for 4-6 months, either Folfox4 or fluorouracil, depending on the center's choice.

Treatment:

Radiation: Radiotherapy 50 Gy

Radiation: Radiotherapy 50 Gy

Drug: Fluorouracil/folic acid

Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen

Experimental group

Description:

Neoadjuvant CT FOLFOX4, 8 cycles (ca. 4 months; each cycle = 2 weeks): 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).

Treatment:

Radiation: Radiotherapy 50 Gy

Radiation: Radiotherapy 50 Gy

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