Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

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

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.

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.

Inclusion Criteria:

• Locally recurrent rectal cancer
• Previous pelvic RT for rectal cancer and surgery
• Potentially resectable by MRI and palpation by MDT evaluation
• Absence of non-resectable distant metastases by PET-CT
• Age ≥ 18
• Adequate organ function
• Acceptable bowel and bladder function
• Acceptance for TR sampling

Exclusion Criteria:

• Central small recurrences deemed immediate resectable
• Previous radiotherapy <12 month prior to recurrence
• Non-resectable systemic or regional disease
• Unable to undergo MRI or PET-CT
• Medical comorbidities precluding radical surgery