Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

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.

40.8Gy/34 fractions (1.2Gy BID 5/7 days with minimum 6 hours interval) Concurrent capecitabine (825 mg/m2 BID 5/7 days)

Hyperfractionated external beam radiation

Karen-Lise G Spindler, MD, Phd

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.

Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.

Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

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

IPDs will not be available to other researchers according to National General data protection regulations. However, data will be published according to guidelines.

Rate of complete pathological resection R0

Clinical and laboratory AEs (Adverse Events) will be graded according to NCICTCAE (version 4.0).

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.

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.

Potential organ at risk sparing when comparing photons vs protons - comparative dose planning

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients	NCT05816980	Rectal Cancer Recurrence Radiation Toxic...	Hyperfractionat...	18 Years -	Aarhus University Hospital
Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients	NCT05816980	Rectal Cancer Recurrence Radiation Toxic...	Hyperfractionat...	18 Years -	Aarhus University Hospital

Spots Global Cancer Trial Database for hyperfractionated external beam radiation