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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity

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Trial Information

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


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.

Inclusion 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

- 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Transportability of intensity-modulated radiotherapy technique in a multi0institytuibal setting

Principal Investigator

Nancy Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000269314

NCT ID:

NCT00057785

Start Date:

February 2003

Completion Date:

Related Keywords:

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

Name

Location

Akron City HospitalAkron, Ohio  44304
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of California Davis Cancer CenterSacramento, California  95817
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
McKay-Dee Hospital CenterOgden, Utah  84403
Northeast Georgia Medical CenterGainesville, Georgia  30501
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Albuquerque Regional Medical Center at Lovelace Sandia Health SystemAlbuquerque, New Mexico  87102