Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Rectal Cancer Recurrence Radiation Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Hyperfractionated external beam radiation

Intervention Type 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)

Interventions

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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)

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No