Radiation Toxicity, Rectal Cancer, Recurrence
Conditions
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.
Interventions
RADIATIONHyperfractionated 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)
Sponsors
Oslo University Hospital
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resection rate | At surgery | Rate of complete pathological resection R0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
Denmark, Norway
Outcome results
None listed