Status:
TERMINATED
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.
Detailed Description
Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive r...
Eligibility Criteria
Inclusion
- Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
- Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
- The tumor is located in the hard palate or the retromolar region.
- Poorly differentiated cell type.
- Tumor invasion to the nerve.
- Tumor invasion to lymphatic vessels.
- Tumor invasion to the small blood vessels.
- Tumor invasion to the bone.
- Tumor invasion to the skin.
- Depth of tumor invasion ≧ 10mm.
- Occurred in single lymph node metastasis.
Exclusion
- No or presence of adverse prognostic factor but less than 2.
- Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
- ECOG performance status \> 2.
- Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
- Women during pregnancy.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00937612
Start Date
June 1 2008
End Date
March 1 2014
Last Update
February 8 2017
Active Locations (3)
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1
Chang Gung Memorial Hospital, Keelung branch
Keelung, Taiwan, 222
2
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, Taiwan, 333
3
Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch
Taoyuan District, Taiwan, 333