Status:
TERMINATED
Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Sanofi
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase...
Detailed Description
Adjuvant treatment of resected head and neck cancers The incidence of locoregional failures and distant metastasis is high after primary resection of squamous cell carcinoma of the head and neck (HNSC...
Eligibility Criteria
Inclusion
- All subjects must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites include: oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis subglottis). Nasopharynx primary will be excluded.
- The resected tumor must have one or more of the following high risk features: histologic extracapsular nodal extension involvement of ≥ 2 regional lymph nodes, mucosal margin of resection with invasive cancer (limited to microscopic detection only), tumor with perineural invasion, tumor with lymphovascular invasion, oral cavity and oropharynx carcinomas with positive lymph nodes metastasis at level IV or V.
- Radiation must begin within 28 to 56 days after surgical resection.
- All subjects must be 18 years of age or older.
- Subjects must have a Zubrod performance of 0-2.
Exclusion
- Subjects must not have distant metastatic disease (M1).
- Subjects must NOT have prior therapy with oxaliplatin.
- Subjects with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with severe psychiatric disorder are not eligible.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00256308
Start Date
February 1 2005
End Date
October 1 2011
Last Update
May 1 2018
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868