Clinical trial NCT00068237: Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Radiation Toxicity
Xerostomia
Keywords: 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
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
timeFrame: At the time of the submandibular salivary gland transfer
Secondary outcomes:
measure: Percentage of Patients With Acute Xerostomia
timeFrame: From start of treatment to 90 days
measure: Percentage of Patients With Normal Functioning Transferred Submandibular Gland
timeFrame: Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
measure: Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
timeFrame: Baseline and one year
measure: Percentage of Patients Experiencing Facial Edema Following Surgery
timeFrame: From surgery to 30 days after surgery
measure: Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy
timeFrame: From start of radiation therapy to 90 days
measure: Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy
timeFrame: From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.
measure: Disease-free Survival Rate at 2 Years
timeFrame: From registration to two years
measure: Overall Survival Rate at 2 Years
timeFrame: From registration to two years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
city: Springfield
country: United States
facility: Cancer Institute at St. John's Hospital
state: Illinois
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute at University of Alberta
state: Alberta
city: St. John's
country: Canada
facility: Doctor H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
Study officials:
affiliation: Cross Cancer Institute at University of Alberta
name: Naresh Jha, MBBS
role: STUDY_CHAIR
References:
citation: Jha N, Harris J, Seikaly H, Jacobs JR, McEwan AJ, Robbins KT, Grecula J, Sharma AK, Ang KK. A phase II study of submandibular gland transfer prior to radiation for prevention of radiation-induced xerostomia in head-and-neck cancer (RTOG 0244). Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):437-42. doi: 10.1016/j.ijrobp.2012.02.034. Epub 2012 Apr 27.