Clinical trial NCT00057785: Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
Official title: A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity
Keywords: oral complications of radiation therapy
radiation toxicity
stage I squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-09
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
timeFrame: From start of treatment to end of treatment
Secondary outcomes:
measure: Rate of Xerostomia at 1 Year (Grade ≥ 2)
timeFrame: From start of treatment to 1 year
measure: Rate of Locoregional Control at 2 Years
timeFrame: From registration to 2 years
measure: Whole Mouth Saliva Output Relative to Pretreatment Measurements
timeFrame: From start of treatment to 1 year
measure: Other Acute and Late Toxicities
timeFrame: From start of treatment to last follow-up
measure: Chemotherapy Compliance
timeFrame: From start of treatment to end of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Comprehensive Cancer Center at University of Alabama at Birmingham
state: Alabama
city: Davis
country: United States
facility: University of California Davis Cancer Center
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento Medical Group, Incorporated
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: St Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital
state: Missouri
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Regional Medical Center at Lovelace Sandia Health System
state: New Mexico
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase-Temple Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
city: Lackland AFB
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Ogden
country: United States
facility: McKay-Dee Hospital Center
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: STUDY_CHAIR
References:
citation: 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 quality assurance guidelines from RTOG 0225. Technol Cancer Res Treat. 2010 Jun;9(3):291-8. doi: 10.1177/153303461000900308.
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 II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.
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.