A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2011-08-31

Brief Summary

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The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

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Detailed Description

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Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Conditions

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Malignant Rectal Neoplasm Recurrent Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intraoperative radiotherapy

Group Type EXPERIMENTAL

intraoperative radiotherapy

Intervention Type RADIATION

intraoperative radiotherapy

Interventions

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intraoperative radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* locally advanced or recurrent rectal cancer
* suitable for radical surgery but at high risk of positive resection margins,
* no evidence of metastasis,
* age greater than 18 years,
* histologically confirmed adenocarcinoma,
* ECOG performance status \<2.
* Informed consent