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Status unknownNCT00232960Updated Mar 28, 2012

Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC

An interventional study of Radiotherapy 50 Gy in Oral Cancer and Oropharynx Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-28.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
310
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Oral Cancer
  • Oropharynx Cancer

Keywords

  • oral and oropharynx carcinoma
  • surgery
  • postoperative radiotherapy
  • molecular analysis
  • microsatellite instability
03

In context

Mouth Neoplasms

377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.

This study's enrollment of 310 is above the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.

Browse Mouth Neoplasms studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Vallecula carcinoma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
310 participants (actual)

Interventions

  • ProcedureRadiotherapy 50 Gy
06

What researchers measure

Primary outcomes

  1. loco-regional control

    Time frame: 5 years

07

Study locations

4 sites
  • Centre Francois Baclesse
    Caen, 14000, France
  • Hôpital de la Croix Rousse
    Lyon, France
  • Centre Alexis Vautrin
    Vandoeuvre les Nancy, 54511, France
  • Institut Gustave Roussy
    Villejuif, 94800, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00232960
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Tumor Study Group Head and Neck
Responsible party
Sponsor
First posted
Oct 5, 2005
Start date
Oct 2005
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Mar 28, 2012

Study contacts

Stephane Temam
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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