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

Primary Purpose

Head and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
fluorouracil
Intensity modulated radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • University of California Davis Cancer Center
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • UCSF Comprehensive Cancer Center
  • Northeast Georgia Medical Center
  • Mayo Clinic Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Monmouth Medical Center
  • Albuquerque Regional Medical Center at Lovelace Sandia Health System
  • Akron City Hospital
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase-Temple Cancer Center
  • CCOP - MainLine Health
  • M.D. Anderson Cancer Center at University of Texas
  • Wilford Hall Medical Center
  • McKay-Dee Hospital Center
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT +/- chemotherapy

Arm Description

Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2003
Last Updated
December 30, 2016
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00057785
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT +/- chemotherapy
Arm Type
Experimental
Arm Description
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
Intervention Type
Radiation
Intervention Name(s)
Intensity modulated radiation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
Description
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.
Time Frame
From start of treatment to end of treatment
Secondary Outcome Measure Information:
Title
Rate of Xerostomia at 1 Year (Grade ≥ 2)
Time Frame
From start of treatment to 1 year
Title
Rate of Locoregional Control at 2 Years
Time Frame
From registration to 2 years
Title
Whole Mouth Saliva Output Relative to Pretreatment Measurements
Time Frame
From start of treatment to 1 year
Title
Other Acute and Late Toxicities
Time Frame
From start of treatment to last follow-up
Title
Chemotherapy Compliance
Time Frame
From start of treatment to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California Davis Cancer Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Albuquerque Regional Medical Center at Lovelace Sandia Health System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase-Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20441239
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.
Results Reference
result
PubMed Identifier
19564532
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.
Results Reference
result
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.
Results Reference
result

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

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