Recruiting NCT04695782
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pencil beam proton radiotherapy.
- Who it may be relevant to
- Registry conditions: Rectal Cancer Recurrent. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Radiation Pencil beam proton radiotherapy
Doseescalated pencil beam proton Therapy
Primary outcome measures
- R0-resection [Time frame: 5-6 years]
- 1-year local control [Time frame: 6-7 years]
Secondary outcome measures (5)
- Local recurrence [Time frame: 6-8 years]
- Disease free survival [Time frame: 10 years]
- Overall survival [Time frame: 10 years]
- Toxicity [Time frame: 5-7 years]
- Patient reported outcomes [Time frame: 5-7 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Danish Centre for Particle Therapy — Aarhus
Identifiers
NCT: NCT04695782 · DCPT221020