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

Sponsor:	NCC Head and Neck Clinic
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003637

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response [ Designated as safety issue: No ]
Distant metastases [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 1998

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003637

Locations

Singapore
National Cancer Centre - Singapore
Singapore, Singapore, 169610

Sponsors and Collaborators

NCC Head and Neck Clinic

Investigators

Study Chair:

Eu J. Chua, MD

National Cancer Centre, Singapore

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00003637 History of Changes
Other Study ID Numbers:	CDR0000066722, NMRC-SQNP01, EU-98047
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx

Additional relevant MeSH terms:

Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin

Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012