Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068237

Purpose

RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).

PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer Radiation Toxicity Xerostomia	Drug: radioprotection Procedure: conventional surgery Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	A Phase II Study Of Submandibular Salivary Gland Transfer To The Submental Space Prior To Start Of Radiation Treatment For Prevention Of Radiation-Induced Xerostomia In Head And Neck Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reproducibility

Secondary Outcome Measures:

Rate of acute xerostomia
Salivary scan evaluation
Quality of life
Toxicity
Disease-free survival
Overall survival

Estimated Enrollment:	48
Study Start Date:	August 2003

Detailed Description:

OBJECTIVES:

Determine the reproducibility of the surgical technique of submandibular salivary gland transfer in patients with head and neck cancer.
Determine the rate and severity of radiation-induced xerostomia after this surgery in these patients.
Determine the pattern of recurrence, disease-free survival, and overall survival of patients treated with this surgery followed by radiotherapy.
Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgical transfer of the submandibular salivary gland to the submental space.

Within 4-6 weeks after surgery, patients undergo radiotherapy once daily, 5 days a week for 5 ½ to 7 weeks in the absence of disease progression or unacceptable toxicity.

Salivary scans are performed before surgery, at 2-3 weeks after surgery, and then at 6 months from the start of radiotherapy.

Quality of life is assessed at baseline and at 3, 6, and 12 months from the start of radiotherapy.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 11-48 patients will be accrued for this study within 1.6 years.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:
- Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Head and neck cancer of unknown primary with unilateral metastases to the neck nodes
No N3 disease
No carcinoma of the oral cavity or nasopharynx
No bilateral neck node involvement
No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI
No pre-epiglottic space involvement
No involvement of level 1 nodes on either side of the neck
No salivary gland malignancy
No recurrent disease

PATIENT CHARACTERISTICS:

Age

18 to 80

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin at least 10 g/dL

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No salivary gland disease (e.g., Sjögren's syndrome)
No other malignancy within the past 3 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 3 years since prior chemotherapy
No prior or concurrent neoadjuvant chemotherapy
Concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed

Endocrine therapy

Not specified

Radiotherapy

See Chemotherapy
No prior radiotherapy to the head and neck
No concurrent intensity-modulated radiotherapy

Surgery

Not specified

Other

No concurrent cholinergic drugs
No concurrent anti-cholinergic drugs
No concurrent tricyclic drugs
No concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068237

Locations

United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Illinois
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Jha Naresh, MBBS

Cross Cancer Institute at University of Alberta

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000287213, RTOG-0244
Study First Received:	September 10, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00068237 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

xerostomia
radiation toxicity
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx

stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
untreated metastatic squamous neck cancer with occult primary
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

Stomatognathic Diseases
Salivary Gland Diseases
Xerostomia

ClinicalTrials.gov processed this record on November 27, 2009