Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients (Re-RAD-I)

Aarhus University Hospital

Status and phase: Completed; Phase 2

Conditions: Radiation Toxicity; Recurrence; Rectal Cancer

Treatments: Radiation: Hyperfractionated external beam radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05816980

KFE-1506

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Single

Other group

Description:

Re-irradiation consisting of hyperfractionated IMRT, 40.8 Gy in 1.2 fractions twice daily 5/7 days weekly, with oral capecitabine 825 mg/m2 BID on radiotherapy treatment days. Re-staging performed 4-6 weeks after the last dose, followed by surgery, when feasible.

Treatment:

Radiation: Hyperfractionated external beam radiation