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NCT04695782: ReRad II

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

Recruiting now Phase 2 Last updated 5 January 2021
What this trial tests

Phase 2 trial testing Pencil beam proton radiotherapy in Rectal Cancer Recurrent in 65 participants. Currently enrolling.

Timeline
10 October 2020
Primary endpoint
31 October 2025
31 October 2028

Quick facts

Lead sponsorUniversity of Aarhus
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment65
Start date10 October 2020
Primary completion31 October 2025
Estimated completion31 October 2028
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Rectal Cancer Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inter-fraction motion robustness in a prospective phase II trial on dose-escalated proton reirradiation for locally recurrent rectal cancer.
    Truelsen CG, Rønde HS, Kallehauge JF, Poulsen LØ, et al · · 2024 · cited 3× · PMID 39286771 · DOI 10.1016/j.phro.2024.100634
  2. PTCOG Gastrointestinal Subcommittee Lower Gastrointestinal Tract Malignancies Consensus Statement.
    Isabelle Choi J, Wojcieszynski A, Amos RA, Giap H, et al · · 2024 · cited 3× · PMID 38757077 · DOI 10.1016/j.ijpt.2024.100019
  3. Acute toxicity and quality of life in dose-escalated proton reirradiation for locally recurrent rectal cancer: The prospective ReRad II trial.
    Truelsen CG, Rønde HS, Kallehauge JF, Szpejewska JE, et al · · 2025 · PMID 40677620 · DOI 10.1016/j.ctro.2025.100999
  4. Comparing robust proton versus online adaptive photon radiotherapy for short-course treatment of rectal cancer.
    Hundvin JA, Hege Lilleøren U, Valdman A, Sorcini B, et al · · 2024 · PMID 39559486 · DOI 10.1016/j.phro.2024.100663

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