Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Recruiting
Phase 2Interventional Study
Rectal Cancer Recurrent
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
65 (estimated)
Sponsor
University of Aarhus · Other
Who this trial is looking for
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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.
Trial Locations
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City
State
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Status
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
* …
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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