Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

Aarhus University Hospital16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer Recurrence Radiation Toxicity

Interventions

Hyperfractionated external beam radiationRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Aarhus University Hospital

Aarhus, Denmark

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Resection rate

Rate of complete pathological resection R0

Time frame: At surgery

Secondary Outcomes

Physician reported Toxicity

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

Time frame: Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery

QoL assessment according to QLQ-CR29

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.

Time frame: 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.

Time frame: Pre-treatment and 12 months post surgery

Recurrence rate

Rate of re-recurrence

Time frame: Rate of re-recurrence at 6, 12 and 36 months post surgery.

Comparative dose planning study

Data from ClinicalTrials.gov

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