Overview
No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
Status:
Recruiting
Recruiting
Trial end date:
2023-10-30
2023-10-30
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Servicio de Salud Metropolitano Sur OrienteTreatments:
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.