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

Phase 2

Completed

• Conditions: Radiation Toxicity; Head and Neck Cancer; Xerostomia
• Interventions: Procedure: salivary gland transfer; Radiation: Post-operative radiation therapy

• Registration Number: NCT00068237
• Lead Sponsor: Radiation Therapy Oncology Group

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Primary Completion: 2008-01
• Results First Submitted: 2013-10-29
• Results First Submitted QC: 2013-12-27
• Results First Posted: 2014-01-31
• Study Completion: 2016-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery + Transfer + Radiation	Post-operative radiation therapy	Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Surgery + Transfer + Radiation	salivary gland transfer	Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.

Primary Outcome Measures

Name	Time	Method
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"	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 Outcome Measures

Name	Time	Method
Overall Survival Rate at 2 Years	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.
Percentage of Patients With Normal Functioning Transferred Submandibular Gland	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.
Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire	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.
Percentage of Patients Experiencing Facial Edema Following Surgery	From surgery to 30 days after surgery	Facial edema was noted as present or absent following surgery.
Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy	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.
Disease-free Survival Rate at 2 Years	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.
Percentage of Patients With Acute Xerostomia	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).
Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy	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.

Trial Locations

Locations (12)

University of Florida Shands Cancer Center; 🇺🇸 Gainesville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami; 🇺🇸 Miami, Florida, United States

Cancer Institute at St. John's Hospital; 🇺🇸 Springfield, Illinois, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

Medical College of Wisconsin Cancer Center; 🇺🇸 Milwaukee, Wisconsin, United States

Josephine Ford Cancer Center at Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Veterans Affairs Medical Center - Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States

Doctor H. Bliss Murphy Cancer Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Cross Cancer Institute at University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Centre Hospitalier Universitaire de Quebec; 🇨🇦 Quebec City, Quebec, Canada