Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00057785

First received: April 7, 2003

Last updated: August 12, 2010

Last verified: November 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2003

Last Updated Date

August 12, 2010

Start Date ^ICMJE

February 2003

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Transportability of intensity-modulated radiotherapy technique in a multi0institytuibal setting
Intensity-modulated radiotherapy treatment compliance rate

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00057785 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of xerostomia at 1 year (grade ≥ 2)
Rate of locoregional control at 2 years
Whole mouth saliva output relative to pretreatment measurements
Other acute and late toxicities
Chemotherapy compliance

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

Official Title ^ICMJE

A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.

Detailed Description

OBJECTIVES:

Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens.
Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens.
Determine the acute and late toxicity of these regimens in these patients.
Determine chemotherapy compliance in patients treated with these regimens.

OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or unacceptable toxicity.

Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over 20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.

Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12 months after IMRT.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40 months.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity

Intervention ^ICMJE

Drug: cisplatin
Drug: fluorouracil
Procedure: adjuvant therapy
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Radiation: radiation therapy

Study Group/Cohort (s)

Not Provided

Publications *

Chen AM, Lee NY, Yang CC, Liu T, Narayan S, Vijayakumar S, Purdy JA. Comparison of intensity-modulated radiotherapy using helical tomotherapy and segmental multileaf collimator-based techniques for nasopharyngeal carcinoma: dosimetric analysis incorporating quality assurance guidelines from RTOG 0225. Technol Cancer Res Treat. 2010 Jun;9(3):291-8.
Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-Modulated Radiation Therapy With or Without Chemotherapy for Nasopharyngeal Carcinoma: Radiation Therapy Oncology Group Phase II Trial 0225. J Clin Oncol. 2009 Jun 29; [Epub ahead of print]
Lee NY, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT ± chemotherapy for nasopharyngeal carcinoma (RTOG 0225): preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-23, S13-14, 2007.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
- WHO I-III
- No stage IVC disease
- No evidence of distant metastasis
Measurable or evaluable disease
Must have been treated with primary radiotherapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

WBC at least 4,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Not specified

Renal

Creatinine no greater than 1.6 mg/dL
Creatinine clearance at least 60 mL/min

Other

Not pregnant*
Negative pregnancy test*
No other prior head and neck cancer
No other malignancy within the past 5 years except nonmelanoma skin cancer
No active untreated infection
No other major medical or psychiatric illness that would preclude study entry
Nutritional and general physical condition compatible with radiotherapy NOTE: *If stage T2b or greater or node-positive disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 6 months since prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
More than 6 months since prior radiotherapy for head and neck cancer

Surgery

No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies

Other

No other concurrent experimental therapy for cancer
No amifostine or pilocarpine during or for 3 months after radiotherapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00057785

Other Study ID Numbers ^ICMJE

CDR0000269314, RTOG-0225

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Radiation Therapy Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Nancy Lee, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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