Radiation Therapy Alone Compared to Radiation Therapy Plus Chemotherapy in Treating Patients With Previously Untreated Cancer of the Nasopharynx

Head and Neck Cancer Clinical Trial

Official title:

Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003637
• Other study ID #: CDR0000066722
• Secondary ID: NMRC-SQNP01EU-98
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: September 1998

Study information

• Verified date: January 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is more effective than radiation therapy plus chemotherapy in treating cancer of the nasopharynx.

PURPOSE: This randomized phase III trial is studying how well radiation therapy and chemotherapy works compared to radiation therapy alone in treating patients with previously untreated cancer of the nasopharynx.

Description:

OBJECTIVES:

• Compare the clinical response, distant metastases, disease-free survival, and overall survival in patients with previously untreated, locally advanced, nonmetastatic nasopharyngeal cancer treated with radiotherapy alone vs concurrent chemoradiotherapy followed by adjuvant chemotherapy.

OUTLINE: This is a randomized study.

Patients are randomized to receive radiotherapy alone (arm I) or concurrent chemoradiotherapy followed by adjuvant chemotherapy (arm II).

• Arm I: Patients receive radiotherapy once daily 5 times a week for 7 weeks.

• Arm II: Patients receive cisplatin IV over 6-8 hours for 4 consecutive days every 3 weeks for 3 courses. Concurrent radiotherapy is given once daily 5 times a week over the 7 week treatment period. This chemoradiotherapy is followed 3 weeks later by adjuvant chemotherapy. Patients receive cisplatin IV and fluorouracil IV over 6-8 hours for 4 consecutive days every 4 weeks for 3 courses.

Patients are followed every 4 months for the first year, every 6 months for the next 2 years, and then annually thereafter until death.

PROJECTED ACCRUAL: A minimum of 200 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed nasopharyngeal cancer that is previously untreated WHO Type III

• Stage III/IV (T3-4 Nx M0 or Tx N2-3 M0) confirmed by CT PNS

• No evidence of distant metastases detected on chest x-ray, bone scan, and liver ultrasound

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• SAP and SGOT less than 2 times upper limit of normal

• Bilirubin less than 1.4 mg/dL

Renal:

• Creatinine less than 1.6 mg/dL

• Creatinine clearance greater than 50 mL/min

Other:

• No other malignant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• See Disease Characteristics

• No concurrent aminoglycoside antibiotics

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Singapore	National Cancer Centre - Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response			No
Primary	Distant metastases			No
Primary	Disease-free survival			No
Primary	Overall survival			No