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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00068237
First received: September 10, 2003
Last updated: February 5, 2014
Last verified: February 2014
  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
Procedure: Surgery for the primary and neck nodes
Procedure: Submandibular salivary gland transfer
Radiation: Post-operative radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" [ Time Frame: At the time of the submandibular salivary gland transfer ] [ Designated as safety issue: No ]
    Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.


Secondary Outcome Measures:
  • Rate of Acute Xerostomia [ Time Frame: From start of treatment to 90 days ] [ Designated as safety issue: Yes ]
  • Salivary Scan Evaluation [ Time Frame: From start of treatment to 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: From registration to 1 year ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: From start of treatment to last follow-up ] [ Designated as safety issue: Yes ]
  • Disease-free Survival [ Time Frame: From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From registration to date of death or last follow-up ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: August 2003
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery and salivary gland transfer and radiation
Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
Procedure: Surgery for the primary and neck nodes Procedure: Submandibular salivary gland transfer Radiation: Post-operative radiation therapy

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 and then annually.

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 and older
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

  • At least 18 years old

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Naresh Jha, MBBS Cross Cancer Institute at University of Alberta
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00068237     History of Changes
Other Study ID Numbers: RTOG-0244, CDR0000287213
Study First Received: September 10, 2003
Results First Received: October 29, 2013
Last Updated: February 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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:
Head and Neck Neoplasms
Xerostomia
Radiation Injuries
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014