Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

NCT05378919 | Recruiting Phase 2

• 1 other identifier: RECTUM2015
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

Outcome Measures

Primary Outcomes (1)

• disease-free survival

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

  3 year

Secondary Outcomes (1)

• Overall survival

  7 year

Study Arms (2)

Arm A (Control): Radiotherapy + fluorouracil

ACTIVE COMPARATOR

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.

Radiation: Radiotherapy 50 Gy; Drug: Fluorouracil/folic acid

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

EXPERIMENTAL

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).

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

Interventions

Radiotherapy 50 Gy RADIATION

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

Arm A (Control): Radiotherapy + fluorouracil

Fluorouracil/folic acid DRUG

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

Arm A (Control): Radiotherapy + fluorouracil

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Rita Ambraziene

Kaunas, 45304, Lithuania

RECRUITING

MeSH Terms

Interventions

Fluorouracil; Folic Acid; Drug Therapy; Clinical Protocols; Oxaliplatin; Leucovorin

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Rita Ambraziene

CONTACT

+37037326196; rita.ambraziene@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 18, 2022
• Study Start: June 1, 2015
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

LI (1)