NCT04695782 Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
| NCT ID | NCT04695782 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Aarhus |
| Condition | Rectal Cancer Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2020-10-10 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 65 participants in total. It began in 2020-10-10 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study design: A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04695782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04695782 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04695782 currently recruiting?
Yes, NCT04695782 is actively recruiting participants. Contact the research team at camkro@rm.dk for enrollment information.
Where is the NCT04695782 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT04695782 clinical trial?
NCT04695782 is sponsored by University of Aarhus. The trial plans to enroll 65 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.