Phase 3 N=69 Randomized Treatment

Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00608205 ↗

Enrolled (actual)

Serious AEs

30.4%

Results posted

Sep 2013

Primary outcome: Primary: Relapse Free Survival — 30; 28 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: cisplatin (Drug); fluorouracil (Drug); radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Case Comprehensive Cancer Center
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Relapse Free Survival	30; 28	—
SECONDARY Patterns of Failure	1; 1; 1; 0; 4; 4	—
SECONDARY Overall Survival	34; 29	—
SECONDARY Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor	35; 28	—
SECONDARY Number of Patients With a Pathological(Final)Complete Response	35; 31	—
SECONDARY Disease Recurrence	5; 2	—
SECONDARY Number of Patients That Required a Feeding Tube	0; 0	—
SECONDARY Number of Patients That Required a Feeding Tube	0; 0	—
SECONDARY Number of Patients That Required a Feeding Tube	0; 0	—
SECONDARY Number of Patients That Required a Feeding Tube	0; 0	—
SECONDARY Nausea Level	0.10; 0	—
SECONDARY Nausea Level	0.10; 0	—
SECONDARY Nausea Level	0.10; 0	—
SECONDARY Nausea Level	0.10; 0	—
SECONDARY Dry Mouth	2.60; 2.94	—
SECONDARY Dry Mouth	2.60; 2.94	—
SECONDARY Dry Mouth	2.60; 2.94	—
SECONDARY Dry Mouth	2.60; 2.94	—
SECONDARY Pain	0.60; 0.75	—
SECONDARY Pain	0.60; 0.75	—
SECONDARY Pain	0.60; 0.75	—
SECONDARY Pain	0.60; 0.75	—
SECONDARY Quality of Life	0.62; 0.88	—
SECONDARY Quality of Life	0.62; 0.88	—
SECONDARY Quality of Life	0.62; 0.88	—
SECONDARY Quality of Life	0.62; 0.88	—
SECONDARY Eating	1.52; 1.13	—
SECONDARY Eating	1.52; 1.13	—
SECONDARY Eating	1.52; 1.13	—
SECONDARY Eating	1.52; 1.13	—
SECONDARY Swallowing	1.45; 1.63	—
SECONDARY Swallowing	1.45; 1.63	—
SECONDARY Swallowing	1.45; 1.63	—
SECONDARY Swallowing	1.45; 1.63	—
SECONDARY Alcohol Consumption	2.85; 2.81	—
SECONDARY Alcohol Consumption	2.85; 2.81	—
SECONDARY Alcohol Consumption	2.85; 2.81	—
SECONDARY Alcohol Consumption	2.85; 2.81	—
SECONDARY Solid Foods	0.85; 0.56	—
SECONDARY Solid Foods	0.85; 0.56	—
SECONDARY Solid Foods	0.85; 0.56	—
SECONDARY Solid Foods	0.85; 0.56	—

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, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00608205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.