Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm the value of concurrent chemoradiotherapy in improving the locoregional control and survival of patients with resected locally advanced HNSCC, a phase III randomized study is proposed. The population studied in this trial is limited to patients of oral cavity cancer; this could reduce the confounding factor of varying prognosis in patients of different primary sites of HNSCC.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Buddhist Tzu Chi General Hospital; Changhua Christian Hospital; Chi Mei Medical Hospital; China Medical University Hospital; Kaohsiung Veterans General Hospital.; Koo Foundation Sun Yat-Sen Cancer Center; Mackay Memorial Hospital; National Taiwan University Hospital; Sun Yat-sen University
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

Clinically free of disease after having undergone surgery for histologically confirmed primary keratinizing SCC of the oral cavity.

buccal mucosa upper lip (140.3) lower lip (140.4) cheek (145.0) retromolar area (145.6) bucco-alveolar sulci upper and lower (145.1) oral tongue dorsum (141.1) lateral border (141.2) inferior surface (141.3)

With any one of the risk factors of recurrence listed below:

Nodal extracapsular spread of disease (ECS) Number of positive node > 2 Perineural involvement Lymphovascular emboli/permeation in resected surgical specimen Histologically positive surgical margin

Exclusion Criteria:

Karnofsky performance status of <50 Concurrent or previous second primary cancer (excluding non-melanoma skin cancer) Gross residual disease following surgery Distant metastasis before or at the time of adjuvant treatment Serum creatinine > 1.4 mg/dl, WBC <3500/mm3, platelet <100,000/mm3

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