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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00232960
Other study ID # Marges-ORL
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 4, 2005
Last updated March 27, 2012
Start date October 2005
Est. completion date June 2014

Study information

Verified date March 2012
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 310
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Oral and oropharynx (exclusion vallecula) squamous cell carcinoma

- T1 or T2

- unique, untreated tumor

- N0 or nodes <3cm

- complete pathological resection

- no perineural spread, vascular emboli <5

- pN0 or <=2N+R-

- signed inform consent

Exclusion Criteria:

- Vallecula carcinoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Radiotherapy 50 Gy


Locations

Country Name City State
France Centre Francois Baclesse Caen
France Hôpital de la Croix Rousse Lyon
France Centre Alexis Vautrin Vandoeuvre les Nancy
France Institut Gustave Roussy Villejuif

Sponsors (2)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris Groupe d'Etude des Tumeurs de la Tête Et du Cou

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary loco-regional control 5 years No
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