NCT00068237 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-02-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"

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outcome · POSTED

Percentage of Patients With Acute Xerostomia

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outcome · POSTED

Percentage of Patients With Normal Functioning Transferred Submandibular Gland

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outcome · POSTED

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

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outcome · POSTED

Percentage of Patients Experiencing Facial Edema Following Surgery

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Disease-free Survival Rate at 2 Years

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outcome · POSTED

Overall Survival Rate at 2 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
intervention Names
Procedure: salivary gland transfer
Radiation: Post-operative radiation therapy
label
Surgery + Transfer + Radiation
type
EXPERIMENTAL

interventions

arm Group Labels
Surgery + Transfer + Radiation
description
Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1
name
salivary gland transfer
type
PROCEDURE
arm Group Labels
Surgery + Transfer + Radiation
description
Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.
name
Post-operative radiation therapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 49
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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%.
measure
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

secondary Outcomes

description
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).
measure
Percentage of Patients With Acute Xerostomia
time Frame
From start of treatment to 90 days
description
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.
measure
Percentage of Patients With Normal Functioning Transferred Submandibular Gland
time Frame
Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
description
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.
measure
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
description
Facial edema was noted as present or absent following surgery.
measure
Percentage of Patients Experiencing Facial Edema Following Surgery
time Frame
From surgery to 30 days after surgery
description
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.
measure
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
description
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.
measure
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.
description
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.
measure
Disease-free Survival Rate at 2 Years
time Frame
From registration to two years
description
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.
measure
Overall Survival Rate at 2 Years
time Frame
From registration to two years

Full study description

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.

Source references

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.
pmid
22541957
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice