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A Phase II Study of Adjuvant Chemoradiation With Weekly Oxaliplatin in Patients With High Risk Resected Squamous Cell Carcinoma of the Head and Neck Region


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Phase II Study of Adjuvant Chemoradiation With Weekly Oxaliplatin in Patients With High Risk Resected Squamous Cell Carcinoma of the Head and Neck Region


Inclusion Criteria:



- All subjects must have histologically or cytologically confirmed diagnosis of
squamous cell carcinoma of the head and neck region. The tumor must be considered to
be resectable by one of the two Otolaryngology surgeons (Dr. Armstrong or Dr. Terry
Shibuya).

- 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.

- Subjects must not have distant metastatic disease (M1).

- All subjects must be 18 years of age or older.

- Subjects must have a Zubrod performance of 0-2.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the frequency and severity of toxicities

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Ignatius Ou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 04-40

NCT ID:

NCT00256308

Start Date:

April 2005

Completion Date:

December 2010

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868