Clinical trial NCT00093665: Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
Official title: A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: stage II lymphoepithelioma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.

Detailed description: OBJECTIVES:

Primary

* Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.

Secondary

* Determine overall survival and response rate in patients treated with this regimen.
* Determine compliance to this regimen in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed nasopharyngeal cancer (NPC)

  * Type I-III disease by WHO classification
  * Stage IIB-IVB disease by TNM classification with no distant metastases by chest x-ray, liver ultrasonography or CT scan, and bone scintigraphy

    * Lymph node metastases evaluated by CT scan, MRI, and palpation
  * Progression range of primary lesion evaluated by MRI and pharyngeal fiberoptic endoscopy

PATIENT CHARACTERISTICS:

Age

* 18 to 70

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC \> 3,500/mm\^3
* Platelet count \> 100,000/mm\^3

Hepatic

* No severe hepatic dysfunction

Renal

* Creatinine clearance \> 60 mL/min
* No severe renal dysfunction

Cardiovascular

* No severe cardiac dysfunction

Pulmonary

* No severe pulmonary dysfunction

Other

* No other active cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy for NPC

Chemotherapy

* No prior systemic chemotherapy for NPC

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Primary outcomes:
measure: Progression-free survival at 3 years
Secondary outcomes:
measure: Overall survival
measure: Response rate
measure: Treatment completion rate
measure: Incidence of adverse effects
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: National Hospital Organization - Medical Center of Kure
city: Kanazawa
country: Japan
facility: Kanazawa University
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Nara
country: Japan
facility: Nara Medical University Cancer Center
city: Okinawa
country: Japan
facility: Graduate School of Medical Science at the University of Ryukyu
city: Tsu
country: Japan
facility: Mie University School of Medicine
Study officials:
affiliation: Aichi Cancer Center
name: Nobukazu Fuwa
role: STUDY_CHAIR
References: