Personalized treatment approach for rectal adenocarcinoma
Official title: INTERPRETE: a Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity
Run by Fondazione del Piemonte per l'Oncologia · NCT06952101 · Data updated 2026-11-12
This study is testing a personalized treatment plan for people with rectal adenocarcinoma to see if a mix of less invasive surgeries and special therapies can improve their quality of life and reduce the chance of cancer coming back.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, Turin) |
| Status | Recruiting |
| Started | April 30, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2030 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT06952101 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with high-risk pT1 or cT2-3aN0 rectal adenocarcinoma who are willing to participate in experimental treatment protocols.
✕Probably not a fit
Patients with cT2-4 NM0 who do not achieve clinical complete response or minimal residual disease after treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients with rectal adenocarcinoma, stratifying them into three groups based on their clinical stage. It investigates a multimodal therapeutic approach that emphasizes organ preservation and minimally invasive techniques, such as laparoscopic and robotic surgery, to reduce the impact on patients' quality of life. The study also explores experimental chemoradiotherapy for patients who refuse surgery, aiming to minimize local relapse risk while maintaining a rigorous surveillance protocol. The goal is to provide tailored treatment options that align with the specific needs of each patient group.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with rectal adenocarcinoma.
How similar studies have gone: Other studies have shown promising results with similar organ-sparing and minimally invasive approaches in rectal cancer treatment, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * cT2-4 any NM0 who don't reach cCR or cMR after experimental/standard CRT * Pregnancy
Where it's running
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Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment
Candiolo, Turin, Italy Recruiting
Study contacts
- Principal investigator: Felice Borghi, MD — Fondazione del Piemonte per l'Oncologia
- Study coordinator: Alfredo Mellano, MD
- Email: alfredo.mellano@ircc.it
- Phone: +390119933445
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neoadjuvant Radiotherapy Before Surgery for Locally Advanced Proximal Rectal Cancer
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First-line trastuzumab-deruxtecan with capecitabine and bevacizumab for HER2-positive metastatic colorectal cancer
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This project will see how bowel symptoms (LARS) change over time after sphincter-preserving rectal cancer surgery and whether different neoadjuvant treatment schedules affect those symptoms.
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Rectal brachytherapy boost to try to avoid surgery for low-lying residual rectal cancer after total neoadjuvant therapy
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.