Clinical trial NCT00979680: Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
Official title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: sphincter preservation
neoadjuvant therapy
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2009-09-18
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sphincter preservation rate
timeFrame: surgery
Secondary outcomes:
measure: Tumor response according to rectal endo-echography
timeFrame: prior to surgery
measure: operative mortality and morbidity
timeFrame: after surgery
measure: anatomopathology margins (lateral and inferior)
timeFrame: after surgery
measure: Functional results (stoma closure, continence, manometry)
timeFrame: 2 years
measure: Local recurrence
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 3 years
measure: Overall Survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte catherine
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Clermont-Ferrand
country: France
facility: Hotel Dieu
city: Grenoble
country: France
facility: Hopital Michallon
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: CAC Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nantes
country: France
facility: Centre Rene Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: CRLC Val d'Aurelle
name: Philippe Rouanet, Pr
role: PRINCIPAL_INVESTIGATOR
References: