Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	NMRC-SQNP01 EU-98047, NCT00003637

Objectives

1. 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.

Entry Criteria

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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

Outcomes

Clinical response
Distant metastases
Disease-free survival
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

NCC Head and Neck Clinic

Eu Chua, MD, Protocol chair		Ph: 65-6321-4204 Email: trdcej@nccs.com.sg

Registry Information
Official Title		Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer
Trial Start Date		1998-09-17
Registered in ClinicalTrials.gov		NCT00003637
Date Submitted to PDQ		1998-10-14
Information Last Verified		2006-01-05

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