No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherapy (5x5Gy) followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained (>1year) complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy (CRT), total mesorectal excision (TME) and adjuvant chemotherapy (ACT).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Servicio de Salud Metropolitano Sur Oriente
• Treatments: Capecitabine; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of adenocarcinoma of the rectum

• Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI)

• Tumors < 7cm from anal verge (palpable)

• No prior history of rectal cancer

Exclusion Criteria

• Patients with tumors >7cm from anal verge

• ECOG >1,

• Contraindication for chemotherapy: Hemoglobin <8, White Blood Count <4000, Platelets <100,000, Creatinine Clearance <50ml/min, Total Bilirubin <5mg/dl,

• Stage IV at diagnosis

• Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months.

• Congestive heart failure

• Peripheral neuropathy

• Previous pelvic radiotherapy

• Prior rectal cancer treatment

• Pregnancy or nursery

• Any contraindications to MRI (e.g. patients with pacemakers)

• Indication of pelvic exenteration

• Impossibility to consent.