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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Head and Neck Cancer, Radiation Toxicity, Xerostomia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Reproducibility

Principal Investigator

Jha Naresh, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:

Cross Cancer Institute at University of Alberta

Authority:

United States: Federal Government

Study ID:

CDR0000287213

NCT ID:

NCT00068237

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Radiation Toxicity
  • Xerostomia
  • 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
  • Head and Neck Neoplasms
  • Xerostomia
  • Radiation Injuries

Name

Location

Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295