Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients
Phase III Study Of Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients
1 other identifier
interventional
161
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 1999
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedSeptember 20, 2005
January 1, 2005
September 13, 2005
September 13, 2005
Conditions
Outcome Measures
Primary Outcomes (1)
RT versus RT plus CT in effect on local control and survival of patients of oral cavity cancer after curative operation.
Secondary Outcomes (1)
the acute and chronic toxicity of RT versus RT plus CT in patients of oral cavity cancer after curative operation.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Health Research Institutes, Taiwanlead
- National Taiwan University Hospitalcollaborator
- Changhua Christian Hospitalcollaborator
- China Medical University Hospitalcollaborator
- Buddhist Tzu Chi General Hospitalcollaborator
- Mackay Memorial Hospitalcollaborator
- Koo Foundation Sun Yat-Sen Cancer Centercollaborator
- Chi Mei Medical Hospitalcollaborator
- Kaohsiung Veterans General Hospital.collaborator
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mow-Ming Hsu, MD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
October 1, 1999
Study Completion
August 1, 2009
Last Updated
September 20, 2005
Record last verified: 2005-01