Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer

NCT00093665 | Unknown Phase 2

• 2 other identifiers: AICHI-UHA-HN03-01CDR0000389425
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 3 years

Secondary Outcomes (4)

• Overall survival

• Response rate

• Treatment completion rate

• Incidence of adverse effects

Interventions

cisplatin DRUG

fluorouracil DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aichi Cancer Center: lead

Study Sites (7)

National Hospital Organization - Medical Center of Kure

Hiroshima, 737-0023, Japan

Location

Kanazawa University

Kanazawa, 920-8641, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, 602, Japan

Location

Aichi Cancer Center

Nagoya, 464-8681, Japan

Location

Nara Medical University Cancer Center

Nara, 634-8522, Japan

Location

Graduate School of Medical Science at the University of Ryukyu

Okinawa, 903-0215, Japan

Location

Mie University School of Medicine

Tsu, 514-8507, Japan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Nobukazu Fuwa

  Aichi Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: November 1, 2003
• Last Updated: May 15, 2013

Record last verified: 2006-10

Locations

JP (7)