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NCT Number: NCT05816980

Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Radiation Toxicity Rectal Diseases Rectal Neoplasms Recurrence Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperfractionated external beam radiation

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)

Primary outcomes

  1. Resection rate

    Time frame: At surgery

    Rate of complete pathological resection R0

Secondary outcomes

  1. Physician reported Toxicity

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

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

  2. QoL assessment according to QLQ-CR29

    Time frame: Pre-treatment and 12 months post surgery

    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.

  3. QoL assessment according to EORTC QLQ-C30

    Time frame: Pre-treatment and 12 months post surgery

    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.

  4. Recurrence rate

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

    Rate of re-recurrence

  5. Comparative dose planning study

    Time frame: The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.

    Potential organ at risk sparing when comparing photons vs protons - comparative dose planning

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Acronym: Re-RAD-I

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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