Status:
TERMINATED
S0427, Combination Chemotherapy & RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with previously untreated stage III or IV squamous cell carcinoma of the oropharynx treated with induction chemotherapy comprising doce...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oropharynx by biopsy or fine needle aspiration of the primary lesion or neck mass
- Selected stage III or IV disease
- No T1-2, N1 disease
- No T4b disease
- No other primary tumor sites or unknown primary tumor sites
- Previously untreated disease
- Measurable or non-measurable disease by clinical exam, CT scan or MRI
- Disease considered to be curatively resectable
- Patients for whom surgical excision is unlikely to result in clear margins are not eligible, including patients with any of the following:
- Gross extension of tumor to skull base (e.g., T4b disease)
- Severe trismus
- Pterygoid plate erosion
- Sphenoid bone or foramen ovale involvement
- Direct extension to involve prevertebral-fascia
- Extension to superior nasopharynx or eustachian tube
- Direct extension into the neck with involvement of the deep neck musculature (neck node fixation)
- Suspected invasion (encasement) of the common or internal carotid arteries (T4b)
- Direct extension of neck disease to involve the external skin
- Regional metastases to the supraclavicular neck (IVB low level VB nodes)
- Disease must be appropriate for definitive radiotherapy with curative intent
- No evidence of distant metastases (M1)
- Must have negative chest x-ray
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- No myocardial infarction within the past 3 months
- No unstable or uncontrolled angina
- No active systemic infection
- Granulocyte count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Creatinine \< 1.5 mg/dL
- Bilirubin normal
- Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
- SGOT or SGPT ≤ 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of hypersensitivity reaction to products containing polysorbate 80
- No medical contraindication to surgery as defined by the treating institution
- No clinically significant motor or sensory neuropathy ≥ grade 2
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer from which the patient is in complete remission
- PRIOR CONCURRENT THERAPY:
- No prior therapeutic surgery for head and neck cancer
- No prior radiotherapy
- No prior chemotherapy
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00268372
Start Date
December 1 2005
End Date
December 1 2007
Last Update
October 4 2012
Active Locations (74)
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1
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
2
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
3
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
4
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526