Status:
COMPLETED
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, eith...
Detailed Description
OBJECTIVES: * To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil. * To compare the overall survival, local control without surgery, ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
- No histologic diagnosis other than squamous cell carcinoma
- A primary site must be identified
- Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease
- No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)
- No stage IVC disease (stage IVB disease allowed)
- Deemed appropriate for definitive non-operative management with curative intent
- Resectable disease is not required
- No primary cancer of the nasopharynx, paranasal sinus, or salivary gland
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC \> 3,500/mm³
- Platelet count \> 100,000/mm³
- Serum creatinine \< 2.0 mg/dL
- Alkaline phosphatase \< 2 times normal
- AST \< 2 times normal
- Bilirubin ≤ 2.0 mg/dL
- Serum calcium normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No unstable or uncontrolled angina
- No clinically apparent jaundice
- No active infection
- No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years
- Not a poor compliance risk
- Able to withstand the rigors of intensive treatment
- Available for and compliant with adequate long-term follow-up
- PRIOR CONCURRENT THERAPY:
- No prior definitive surgery or radiotherapy for this malignancy
- No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.
- Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.
- Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.
- Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.
- Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.
- Patients who might be a poor-compliance risk are ineligible.
- Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00608205
Start Date
January 1 2008
End Date
August 1 2016
Last Update
August 6 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195