Status:
RECRUITING
A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity
Lead Sponsor:
Fondazione del Piemonte per l'Oncologia
Conditions:
Rectal Adenocarcinoma
Non Metastatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A phase II, single-center, non-profit, interventional study on patients affected by rectal adenocarcinoma. Patients will be stratified into three groups based on pre-treatment clinical stage. The stud...
Detailed Description
Patients affected by rectal adenocarcinoma will be stratified into three groups according to pre-treatment clinical stage: Group 1: pT1cN0M0 tumors may be candidates for Endoscopic Resection (ER), Lo...
Eligibility Criteria
Inclusion
- Patients aged ≥18 yrs old
- Patients able to sign the informed consent
- Patients with High Risk pT1 rectal adenocarcinoma endoscopically excised
- Patients with cT2-3aN0 rectal adenocarcinoma who has complete/major response to EXPERIMENTAL CRT
- Patients with cT3b4N0-1 rectal adenocarcinoma who has complete/major response to STANDARD CRT
Exclusion
- cT2-4 any NM0 who don't reach cCR or cMR after experimental/standard CRT
- Pregnancy
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06952101
Start Date
April 30 2024
End Date
December 31 2030
Last Update
April 30 2025
Active Locations (1)
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1
Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment
Candiolo, Turin, Italy, 10060