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

Primary Purpose

Rectal Cancer, Recurrence, Radiation Toxicity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Hyperfractionated external beam radiation
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single

Arm Description

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.

Outcomes

Primary Outcome Measures

Resection rate
Rate of complete pathological resection R0

Secondary Outcome Measures

Physician reported Toxicity
Clinical and laboratory AEs (Adverse Events) will be graded according to NCICTCAE (version 4.0).
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.
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.
Recurrence rate
Rate of re-recurrence
Comparative dose planning study
Potential organ at risk sparing when comparing photons vs protons - comparative dose planning

Full Information

First Posted
October 24, 2016
Last Updated
April 14, 2023
Sponsor
Aarhus University Hospital
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05816980
Brief Title
Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients
Acronym
Re-RAD-I
Official Title
External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Recurrence, Radiation Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Hyperfractionated external beam radiation
Intervention Description
40.8Gy/34 fractions (1.2Gy BID 5/7 days with minimum 6 hours interval) Concurrent capecitabine (825 mg/m2 BID 5/7 days)
Primary Outcome Measure Information:
Title
Resection rate
Description
Rate of complete pathological resection R0
Time Frame
At surgery
Secondary Outcome Measure Information:
Title
Physician reported Toxicity
Description
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
Title
QoL assessment according to QLQ-CR29
Description
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
Title
QoL assessment according to EORTC QLQ-C30
Description
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
Title
Recurrence rate
Description
Rate of re-recurrence
Time Frame
Rate of re-recurrence at 6, 12 and 36 months post surgery.
Title
Comparative dose planning study
Description
Potential organ at risk sparing when comparing photons vs protons - comparative dose planning
Time Frame
The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen-Lise G Spindler, MD, Phd
Organizational Affiliation
Aarhus University Hospital, Depart. Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

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