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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057785
• Other study ID #: RTOG-0225
• Secondary ID: CDR0000269314
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2003
• Last updated: October 13, 2015
• Start date: February 2003

Study information

• Verified date: October 2015
• Source: Radiation Therapy Oncology Group
• 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. 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.

Description:

OBJECTIVES:

• Determine the transportability of IMRT to a multi-institutional setting.

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• White blood cell count (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 (If stage T2b or greater or node-positive disease)

• Negative pregnancy test (If stage T2b or greater or node-positive disease)

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Oral Complications of Radiation Therapy
• Radiation Injuries
• Radiation Toxicity

Intervention

Drug:
• cisplatin
100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
• fluorouracil
1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130

Radiation:
• Intensity modulated radiation therapy
The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.

Locations

Country	Name	City	State
United States	Akron City Hospital	Akron	Ohio
United States	Albuquerque Regional Medical Center at Lovelace Sandia Health System	Albuquerque	New Mexico
United States	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama
United States	University of California Davis Cancer Center	Davis	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Fox Chase-Temple Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chen A, Lee N, Yang C, Liu T, Narayan S, Vijayakumar S, Purdy J. Comparison of intensity-modulated radiotherapy using helical tomotherapy and segmental multileaf collimator-based techniques for nasopharyngeal carcinoma: dosimetric analysis incorporating q — View Citation

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 I — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered	Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.	From start of treatment to end of treatment	No
Secondary	Rate of Xerostomia at 1 Year (Grade = 2)		From start of treatment to 1 year	Yes
Secondary	Rate of Locoregional Control at 2 Years		From registration to 2 years	No
Secondary	Whole Mouth Saliva Output Relative to Pretreatment Measurements		From start of treatment to 1 year	No
Secondary	Other Acute and Late Toxicities		From start of treatment to last follow-up	Yes
Secondary	Chemotherapy Compliance		From start of treatment to end of treatment	No