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

Study Overview
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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.

Official Title
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Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

Conditions
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Rectal Cancer

Intervention / Treatment
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* Radiation: High-Dose radiotherapy
* Radiation: Chemo-radiotherapy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-dose Radiotherapy<br> | Radiation: High-Dose radiotherapy<br>* 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.<br>* Other names: HDRT;|
| Active Comparator: Chemo-radiotherapy<br> | Radiation: Chemo-radiotherapy<br>* Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.<br>* Other names: CTRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sphincter preservation rate |  | surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response according to rectal endo-echography |  | prior to surgery | 
| operative mortality and morbidity |  | after surgery | 
| anatomopathology margins (lateral and inferior) |  | after surgery | 
| Functional results (stoma closure, continence, manometry) |  | 2 years | 
| Local recurrence |  | 3 years | 
| Disease-free survival |  | 3 years | 
| Overall Survival |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sphincter preservation, neoadjuvant therapy