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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Oral Cancer Oropharynx Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Radiotherapy 50 Gy

Intervention Type PROCEDURE

Eligibility Criteria

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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