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Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

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

NCT05816980•Aarhus University Hospital

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (2)

Aarhus University Hospital

Aarhus, Denmark

Oslo University Hospital

Oslo, Norway

Key Dates

Start Date

January 1, 2015

Primary Completion Date

January 1, 2019

Completion Date

January 1, 2023

Last Updated

April 18, 2023

Enrollment

ACTUAL participants

Conditions

Rectal CancerRecurrenceRadiation Toxicity

Interventions

Hyperfractionated external beam radiation

RADIATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

Inclusion Criteria

Exclusion Criteria

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