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

December 30, 2016 updated by: Radiation Therapy Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Comprehensive Cancer Center at University of Alabama at Birmingham
    • California
      • Davis, California, United States, 95616
        • University of California Davis Cancer Center
      • Sacramento, California, United States, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Regional Medical Center at Lovelace Sandia Health System
    • Ohio
      • Akron, Ohio, United States, 44304
        • Akron City Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase-Temple Cancer Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center at University of Texas
      • Lackland AFB, Texas, United States, 78236
        • Wilford Hall Medical Center
    • Utah
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT +/- chemotherapy
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
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
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
Time Frame: From start of treatment to end of treatment
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Xerostomia at 1 Year (Grade ≥ 2)
Time Frame: From start of treatment to 1 year
From start of treatment to 1 year
Rate of Locoregional Control at 2 Years
Time Frame: From registration to 2 years
From registration to 2 years
Whole Mouth Saliva Output Relative to Pretreatment Measurements
Time Frame: From start of treatment to 1 year
From start of treatment to 1 year
Other Acute and Late Toxicities
Time Frame: From start of treatment to last follow-up
From start of treatment to last follow-up
Chemotherapy Compliance
Time Frame: From start of treatment to end of treatment
From start of treatment to end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Nancy Lee, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-0225
  • CDR0000269314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on cisplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe