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NCT Number: NCT00068237

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Radiation Injuries Radiation Toxicity Salivary Gland Diseases Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Wounds and Injuries Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

salivary gland transfer

Procedure

Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1

Post-operative radiation therapy

Radiation

Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.

Primary outcomes

  1. 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

    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 outcomes

  1. Percentage of Patients With Acute Xerostomia

    Time frame: From start of treatment to 90 days

    The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).

  2. Percentage of Patients With Normal Functioning Transferred Submandibular Gland

    Time frame: Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)

    Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.

  3. Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire

    Time frame: Baseline and one year

    The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.

  4. Percentage of Patients Experiencing Facial Edema Following Surgery

    Time frame: From surgery to 30 days after surgery

    Facial edema was noted as present or absent following surgery.

  5. Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy

    Time frame: From start of radiation therapy to 90 days

    Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy.

  6. Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy

    Time frame: From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.

    Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Late" refers to toxicities occurring at least 91 days from the start of radiation therapy.

  7. Disease-free Survival Rate at 2 Years

    Time frame: From registration to two years

    Failure was defined as local, regional, or distant recurrence/progression, second primary tumor, or death due to any cause. Disease-free survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Disease-free survival rate is estimated using the kaplan-meier method.

  8. Overall Survival Rate at 2 Years

    Time frame: From registration to two years

    Failure was defined as death due to any cause. Survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Survival rate is estimated using the kaplan-meier method.

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2016
First posted
Sep 11, 2003
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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