Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients (Re-RAD-I)

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrence; Rectal Cancer; Radiation Toxicity
• Intervention / Treatment: Radiation: Hyperfractionated external beam radiation

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single; 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.	Radiation: Hyperfractionated 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection rate	Rate of complete pathological resection R0	At surgery

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Karen-Lise G Spindler, MD, Phd, Aarhus University Hospital, Depart. Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Rectal Neoplasms
• Other Study ID Numbers: KFE-1506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPDs will not be available to other researchers according to National General data protection regulations. However, data will be published according to guidelines.