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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2028
  • participants needed
    65
  • sponsor
    University of Aarhus
Updated on 27 January 2021

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.

Details
Condition Recurrent Rectal Cancer, Rectal Cancer Recurrent
Treatment Pencil beam proton radiotherapy
Clinical Study IdentifierNCT04695782
SponsorUniversity of Aarhus
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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