Pencil beam proton therapy for recurrent rectal cancer
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
This study is testing a special type of radiation therapy called pencil beam proton therapy to see if it can help people with recurrent rectal cancer who have already had radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT04695782 on ClinicalTrials.gov |
What this trial studies
This phase II interventional study investigates the use of dose-escalated pencil beam proton therapy for patients with locally recurrent rectal cancer who have previously undergone radiotherapy. The study aims to evaluate the effectiveness of re-irradiation as either a neo-adjuvant treatment or a definitive strategy for patients with un-resectable recurrences. Participants will receive proton therapy based on a tailored dose plan derived from their prior treatment. The study is observational and non-randomized, focusing on the safety and efficacy of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with locally recurrent rectal adenocarcinoma who have previously received pelvic radiotherapy.
Not a fit: Patients with non-resectable distant metastases or those unable to undergo necessary imaging studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with recurrent rectal cancer, potentially improving their outcomes and quality of life.
How similar studies have performed: While proton therapy is a well-established treatment modality, this specific approach to re-irradiation for recurrent rectal cancer is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Locally recurrent rectal cancer. * Bioptically verified (adenocarcinoma ) * Available dose plan from primary radiotherapy * Previous pelvic RT (\>30Gy EQD2) * Evaluated in MDT-conferences (Herlev, Aarhus) * Age\>18 years * PS 0-2 * Adequate organ function * Informed consent Exclusion Criteria: * Non-resectable distant metastases (PET-CT) * Unable to undergo MRI, PET-CT * Inability to attend full course radiotherapy and follow up in the out patient clinic.
Where this trial is running
Aarhus
- Danish Centre for Particle Therapy — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Camilla Kronborg, MD, PhD
- Email: camkro@rm.dk
- Phone: +45 78450000
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.