Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

Rectal Cancer Clinical Trial

— Re-RAD-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05816980
• Other study ID #: KFE-1506
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: January 2023

Study information

• Verified date: April 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2023
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiation Toxicity
• Rectal Cancer
• Rectal Neoplasms
• Recurrence

Intervention

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)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Oslo University Hospital

Countries where clinical trial is conducted

Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection rate	Rate of complete pathological resection R0	At surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Recurrence rate	Rate of re-recurrence	Rate of re-recurrence at 6, 12 and 36 months post surgery.
Secondary	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.