Status:
COMPLETED
Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Changhua Christian Hospital
Conditions:
Oral Cavity
Squamous Cell Carcinoma
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 rando...
Detailed Description
Potentially resectable Stage III or IV squamous cell carcinomas of the head and neck (HNSCC) are treated by operation and adjuvant radiotherapy. The 5-year survival rate is approximating 30%. Recurren...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00201383
Start Date
October 1 1999
End Date
August 1 2009
Last Update
September 20 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100