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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
cisplatin
fluorouracil
radiation therapy
Sponsored by
Aichi Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Hospital Organization - Medical Center of Kure
  • Kanazawa University
  • Kyoto Prefectural University of Medicine
  • Aichi Cancer Center
  • Nara Medical University Cancer Center
  • Graduate School of Medical Science at the University of Ryukyu
  • Mie University School of Medicine

Outcomes

Primary Outcome Measures

Progression-free survival at 3 years

Secondary Outcome Measures

Overall survival
Response rate
Treatment completion rate
Incidence of adverse effects

Full Information

First Posted
October 6, 2004
Last Updated
May 14, 2013
Sponsor
Aichi Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00093665
Brief Title
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

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aichi Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival at 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Title
Response rate
Title
Treatment completion rate
Title
Incidence of adverse effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobukazu Fuwa
Organizational Affiliation
Aichi Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
National Hospital Organization - Medical Center of Kure
City
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Kanazawa University
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602
Country
Japan
Facility Name
Aichi Cancer Center
City
Nagoya
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nara Medical University Cancer Center
City
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Graduate School of Medical Science at the University of Ryukyu
City
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Mie University School of Medicine
City
Tsu
ZIP/Postal Code
514-8507
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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