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

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%.

Time frame: At the time of the submandibular salivary gland transfer

Population: Eligible patients who started study treatment.

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.

Time frame: Baseline and one year

Population: Eligible patients with both baseline and 1-year questionnaire completed

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.

Time frame: From registration to two years

Population: Eligible patients who started study treatment

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.

Time frame: From registration to two years

Population: Eligible patients who started study treatment

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.

Time frame: From start of radiation therapy to 90 days

Population: Eligible patients who started RT

Facial edema was noted as present or absent following surgery.

Time frame: From surgery to 30 days after surgery

Population: Eligible patients who received the procedure

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.

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.

Population: Eligible patients who started RT and had toxicity data at least 90 days from the end of RT

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).

Time frame: From start of treatment to 90 days

Population: Eligible patients who started RT

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.

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

Population: Eligible patients with salivary scans submitted