Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

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

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2007-09-30

Brief Summary

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This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-dose Radiotherapy

Group Type ACTIVE_COMPARATOR

High-Dose radiotherapy

Intervention Type RADIATION

Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.

Chemo-radiotherapy

Group Type ACTIVE_COMPARATOR

Chemo-radiotherapy

Intervention Type RADIATION

Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Interventions

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High-Dose radiotherapy

Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.

Intervention Type RADIATION

Chemo-radiotherapy

Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Intervention Type RADIATION

Other Intervention Names

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HDRT CTRT

Eligibility Criteria

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Inclusion Criteria

* Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
* Tumor classified as EER UT2-UT3, whatever the nodal status
* pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
* Age 18 years or older
* Informed and written consent

Exclusion Criteria

* T1
* T4 (proven invasion of sphincter)
* Diffuse metastatic syndrome (no curative intent, short expected life span)
* preoperative incontinence (non due to the tumor)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No