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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperfractionated external beam radiation | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate | Rate of complete pathological resection R0 | At surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Physician reported Toxicity | Clinical and laboratory AEs (Adverse Events) will be graded according to NCICTCAE (version 4.0). | Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery |
| QoL assessment according to QLQ-CR29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen-Lise G Spindler, MD, Phd | Aarhus University Hospital, Depart. Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark | |||
| Oslo University Hospital |
IPDs will not be available to other researchers according to National General data protection regulations. However, data will be published according to guidelines.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D012008 | Recurrence |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.
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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.
| Pre-treatment and 12 months post surgery |
| QoL assessment according to EORTC QLQ-C30 | 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. | Pre-treatment and 12 months post surgery |
| Recurrence rate | Rate of re-recurrence | Rate of re-recurrence at 6, 12 and 36 months post surgery. |
| Comparative dose planning study | Potential organ at risk sparing when comparing photons vs protons - comparative dose planning | The VMAT plans generated before treatment start (baseline) is compared to IMPT plans. |
| Oslo |
| 0424 |
| Norway |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |