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Clinical Trials in Denmark / NCT04695782
Recruiting Phase 2

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

NCT04695782 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Phase 2
Started
2020-10-10
Last updated
2021-01-05

Condition(s) studied

Rectal Cancer Recurrent

Investigational drug(s) / intervention(s)

Pencil beam proton radiotherapy

Pencil beam proton radiotherapy: Doseescalated pencil beam proton Therapy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • R0-resection — 5-6 years
    Neo-adjuvant treatment: Rate of pathological complete resection (R0)
  • 1-year local control — 6-7 years
    Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

Trial sites (1)

FacilityCityRegionStatus
Danish Centre for Particle Therapy Aarhus Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04695782 on ClinicalTrials.gov ↗ ← All trials in Denmark