Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2025-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Larissa University Hospital

Criteria

Inclusion Criteria:

• Histologically confirmed rectal adenocarcinoma

• cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1

• Multidisciplinary tumor board decision for neoadjuvant treatment

• Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging

• Patient 18 to 80 years old

• General health condition status WHO 0-1

• Absence of co-morbidities that may affect treatment

• Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min

• Signed informed consent of the patient

Exclusion Criteria:

• Distant metastases

• Non-resectable cancer

• Contraindications for the administration of chemotherapy

• Previous pelvic radiotherapy or chemotherapy

• History of inflammatory bowel disorders

• History of angina, acute myocardial infarction or heart failure

• Active sepsis or systemic infection

• Untreated physical and mental disability

• Synchronous malignancy

• Pregnancy or breast-feeding

• Lack of compliance with the protocol process

• Non-granting of signed informed consent