Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients
- Conditions
- RecurrenceRadiation ToxicityRectal Cancer
- Interventions
- Radiation: Hyperfractionated external beam radiation
- Registration Number
- NCT05816980
- Lead Sponsor
- Aarhus University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Hyperfractionated external beam radiation 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.
- Primary Outcome Measures
Name Time Method Resection rate At surgery Rate of complete pathological resection R0
- Secondary Outcome Measures
Name Time Method Physician reported Toxicity Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery Clinical and laboratory AEs (Adverse Events) will be graded according to NCICTCAE (version 4.0).
QoL assessment according to QLQ-CR29 Pre-treatment and 12 months post surgery Assesment of QoL according to EORTC guidelines. The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC patients. Patients are asked to indicate their symptoms during the past week(s). According to EORTC guidelines, scores can be reported as frequencies of raw scores or scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Comparative dose planning study The VMAT plans generated before treatment start (baseline) is compared to IMPT plans. Potential organ at risk sparing when comparing photons vs protons - comparative dose planning
QoL assessment according to EORTC QLQ-C30 Pre-treatment and 12 months post surgery Assesment of QoL according to EORTC guidelines. The EORTC QLQ-CR30 is a general health related QoL questionnaire. Patients are asked to indicate their symptoms during the past week(s). According to EORTC guidelines, scores can be reported as frequencies of raw scores or scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Recurrence rate Rate of re-recurrence at 6, 12 and 36 months post surgery. Rate of re-recurrence
Trial Locations
- Locations (2)
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Oslo University Hospital
🇳🇴Oslo, Norway