NCT00232960

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

8.7 years

First QC Date

October 4, 2005

Last Update Submit

March 27, 2012

Conditions

Oral CancerOropharynx Cancer

Keywords

oral and oropharynx carcinomasurgerypostoperative radiotherapymolecular analysismicrosatellite instability

Outcome Measures

Primary Outcomes (1)

  • loco-regional control

    5 years

Interventions

Radiotherapy 50 GyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Vallecula carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Francois Baclesse

Caen, 14000, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Mouth NeoplasmsOropharyngeal NeoplasmsMicrosatellite Instability

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic DiseasesGenomic InstabilityPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephane Temam

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 5, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

FR(4)