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Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00008398
Recruitment Status : Completed
First Posted : June 5, 2003
Last Update Posted : November 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Complications Radiation Toxicity Biological: sargramostim Procedure: quality-of-life assessment Radiation: radiation therapy Phase 3

Detailed Description:

OBJECTIVES:

  • Determine the efficacy of sargramostim (GM-CSF) in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy.
  • Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to concurrent cisplatin chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive radiotherapy once daily five days a week for 6-7 weeks. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) three times a week (except on days if receiving concurrent cisplatin) beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks.
  • Arm II: Patients receive radiotherapy as in arm I. Patients also receive placebo SC on the same schedule as GM-CSF in arm I.

Quality of life is assessed at baseline, and then at 3, 6, and 12 months.

Patients are followed at 3, 6 and 11 months.

PROJECTED ACCRUAL: A total of 126 patients (63 per arm) will be accrued within 1.2-1.4 years.


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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
Study Start Date : October 2000
Actual Primary Completion Date : March 2004






Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed head and neck carcinoma with planned external beam radiotherapy to include 50% of oropharynx, oral cavity, or both]
  • Planned external beam radiotherapy of 60-70 Gy total dose to the primary tumor or standard ports for an unknown primary tumor
  • Neck metastases from an unknown primary allowed if radiotherapy planned to at least 50% of the salivary gland at a dose of at least 50 Gy
  • No T1-T2 glottic tumors
  • No residual oral/oropharyngeal injury from prior chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No allergy or idiosyncratic response to sargramostim (GM-CSF)
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy other than cisplatin

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the head and neck

Surgery:

  • Not specified

Other:

  • No concurrent enrollment on other RTOG head and neck studies
  • No concurrent oral care medications (e.g., amifostine, chlorhexidrine gluconate, sucralfate, or benzydamine HCl) during study radiotherapy
  • No concurrent selective oral cavity decontamination (e.g., IB-367) during study radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008398


  Show 236 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Francis G. LeVeque, DDS Barbara Ann Karmanos Cancer Institute

Publications of Results:
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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00008398     History of Changes
Other Study ID Numbers: RTOG-9901
CDR0000068406
NCI-P00-0177
First Posted: June 5, 2003    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Radiation Therapy Oncology Group:
stage I nasopharyngeal cancer
stage II nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
recurrent nasopharyngeal cancer
stage 0 paranasal sinus and nasal cavity cancer
stage 0 nasopharyngeal cancer
stage 0 oropharyngeal cancer
stage 0 laryngeal cancer
stage 0 hypopharyngeal cancer
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
stage 0 lip and oral cavity cancer
stage I lip and oral cavity cancer
stage II lip and oral cavity cancer
stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
recurrent lip and oral cavity cancer
stage I hypopharyngeal cancer
stage II hypopharyngeal cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent hypopharyngeal cancer
stage I paranasal sinus and nasal cavity cancer
stage II paranasal sinus and nasal cavity cancer
stage III paranasal sinus and nasal cavity cancer
stage IV paranasal sinus and nasal cavity cancer
recurrent paranasal sinus and nasal cavity cancer
stage I oropharyngeal cancer
stage II oropharyngeal cancer

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Mucositis
Radiation Injuries
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Wounds and Injuries
Sargramostim
Immunologic Factors
Physiological Effects of Drugs