Personalized treatment approach for rectal adenocarcinoma
INTERPRETE: a Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, Turin) |
| Trial ID | NCT06952101 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with similar organ-sparing and minimally invasive approaches in rectal cancer treatment, indicating potential for success.
Eligibility criteria
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 this trial is running
Candiolo, Turin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.