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Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Oral Cancer, Oropharynx Cancer

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Trial Information

Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

loco-regional control

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Stephane Temam

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Ministry of Health

Study ID:

Marges-ORL

NCT ID:

NCT00232960

Start Date:

October 2005

Completion Date:

June 2014

Related Keywords:

  • Oral Cancer
  • Oropharynx Cancer
  • oral and oropharynx carcinoma
  • surgery
  • postoperative radiotherapy
  • molecular analysis
  • microsatellite instability
  • Carcinoma, Squamous Cell
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms

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