Actively Recruiting
INTERPRETE: A Personalized, Stage-Related Multimodal Approach for Rectal Adenocarcinoma Focusing on Organ Preservation and Minimally Invasive Treatment
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-03-05
200
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized, stage-related, multimodal treatment approach for patients with rectal adenocarcinoma. The study focuses on organ preservation, especially in early-stage tumors, and prioritizes minimally invasive techniques like laparoscopic and robotic surgery to reduce the physical and psychological impact on patients. This phase II, single-center, interventional study aims to improve quality of life while managing rectal cancer effectively. Patients are divided into three groups based on tumor stage before treatment. Group 1 includes patients with early-stage tumors who may undergo local excision or endoscopic resection followed by experimental chemoradiotherapy and a Watch and Wait strategy if surgery is declined. Group 2 involves patients with cT2N0 tumors offered an alternative experimental chemoradiotherapy approach with restaging to decide on organ-sparing strategies or local excision. Group 3 patients with more advanced tumors receive standard chemoradiotherapy and may be considered for organ-sparing methods if they respond well. If organ-sparing is not possible, minimally invasive surgery is performed with nerve preservation and enhanced recovery protocols. Participants undergo thorough imaging and diagnostic assessments including pelvic MRI, CT scans, PET, endorectal ultrasound, and rectoscopy for accurate staging and restaging. The study monitors clinical and pathological responses, quality of life, bowel function, and long-term disease outcomes. Close surveillance follows organ-preserving treatments. The primary outcome is development of a scoring system to predict complete tumor response. Participants are followed for several years to assess survival, quality of life, and bowel function after different treatment approaches.
CONDITIONS
Brief Title
A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 60 years old or older
- Patients able to sign the informed consent
- Patients with high-risk pT1 rectal adenocarcinoma endoscopically excised
- Patients with cT2-3aN0 rectal adenocarcinoma who have complete or major response to experimental chemoradiotherapy
- Patients with cT3b-4N0-1 rectal adenocarcinoma who have complete or major response to standard chemoradiotherapy
You will not qualify if you...
- Patients with cT2-4 any NM0 tumors who do not reach complete or major response after experimental or standard chemoradiotherapy
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo staging assessments including pelvic MRI, CT scan, whole-body PET, and other imaging to determine eligibility and clinical stage.
Duration - Duration varies by treatment and response
Participants receive personalized treatment based on their tumor stage, including experimental chemoradiotherapy or standard chemoradiotherapy. Those with complete or major response may undergo organ-sparing approaches or surgery.
Visits include chemoradiotherapy sessions and multidisciplinary restaging assessments such as MRI, PET, CT scans, ERUS, and rectoscopy.
Duration - Up to 5 years
Participants are closely monitored after treatment with intensive surveillance protocols to detect recurrence and assess outcomes.
Participants attend regular follow-up visits including imaging and clinical assessments at scheduled intervals over several years.
Trial Site Locations
Total: 1 location
1
Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment
Candiolo, Turin, Italy, 10060
Actively Recruiting
Research Team
A
Alfredo Mellano, MD
A
Annamaria Nuzzo, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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