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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Pencil beam proton therapy for recurrent rectal cancer

Official title: Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

Run by University of Aarhus · NCT04695782 · Data updated 2026-11-12

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment65 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations1 site (Aarhus)
StatusRecruiting
StartedOctober 10, 2020
Main results expectedOctober 31, 2025
Study endsOctober 31, 2028
Registry record updatedJanuary 5, 2021
Trial IDNCT04695782 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years with locally recurrent rectal adenocarcinoma who have previously received pelvic radiotherapy.

Probably not a fit

Patients with non-resectable distant metastases or those unable to undergo necessary imaging studies 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 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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Danish Centre for Particle Therapy
    Aarhus, Denmark     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Rectal Cancer Recurrent 2University of Aarhus 153
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.