NCT05816980

Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.

Detailed description

The overall purpose of this trial is to evaluate the efficacy of re-irradiation of patients with locally advanced rectal cancer (LRRC) recurrences who previously received pelvic irradiation. Patients with potentially resectable LRRC will be treated with hyperfractionated Intensity-Modulated Radiotherapy consisting of 40.8 Gy in 1.2 fractions twice daily with concomitant oral capecitabine followed by surgery, when feasible.

Conditions

• Rectal Cancer
• Recurrence
• Radiation Toxicity

Interventions

Type	Name	Description
RADIATION	Hyperfractionated external beam radiation	40.8Gy/34 fractions (1.2Gy BID 5/7 days with minimum 6 hours interval) Concurrent capecitabine (825 mg/m2 BID 5/7 days)

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-01-01
• Completion: 2023-01-01
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

2 sites across 2 countries: Denmark, Norway