Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy (ReRad II)

University of Aarhus

Status and phase: Enrolling; Phase 2

Conditions: Rectal Cancer Recurrent

Treatments: Radiation: Pencil beam proton radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04695782

DCPT221020

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily

Experimental group

Treatment:

Radiation: Pencil beam proton radiotherapy

Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily

Experimental group

Treatment:

Radiation: Pencil beam proton radiotherapy