Clinical trial · Interventional
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy
NCT05378919CI-TRIAL-00058550RECTUM2015recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) | Drug | — | UNRESOLVED |
| Fluorouracil/folic acid | Drug | — | UNRESOLVED |
| Radiotherapy 50 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (Control): Radiotherapy + fluorouracil
- 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.
- interventionNames
- Radiation: Radiotherapy 50 Gy
- Drug: Fluorouracil/folic acid
- type
- EXPERIMENTAL
- label
- Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen
- 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).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.