Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
2019년 2월 1일 업데이트: Radiation Therapy Oncology Group
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
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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
49
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Gainesville, Florida, 미국, 32610-0232
- University of Florida Shands Cancer Center
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Miami, Florida, 미국, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Illinois
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Springfield, Illinois, 미국, 62702
- Cancer Institute at St. John's Hospital
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Michigan
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Detroit, Michigan, 미국, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Ohio
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Columbus, Ohio, 미국, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Texas
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Houston, Texas, 미국, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, 미국, 53295
- Veterans Affairs Medical Center - Milwaukee
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Alberta
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute at University of Alberta
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, 캐나다, A1B 3V6
- Doctor H. Bliss Murphy Cancer Centre
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Quebec
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Quebec City, Quebec, 캐나다, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Surgery + Transfer + Radiation
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
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Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1
Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
Starts within 4-6 weeks of surgery.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
기간: At the time of the submandibular salivary gland transfer
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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%.
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At the time of the submandibular salivary gland transfer
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Patients With Acute Xerostomia
기간: From start of treatment to 90 days
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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).
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From start of treatment to 90 days
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Percentage of Patients With Normal Functioning Transferred Submandibular Gland
기간: Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
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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.
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Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
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Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
기간: Baseline and one year
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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.
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Baseline and one year
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Percentage of Patients Experiencing Facial Edema Following Surgery
기간: From surgery to 30 days after surgery
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Facial edema was noted as present or absent following surgery.
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From surgery to 30 days after surgery
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Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy
기간: From start of radiation therapy to 90 days
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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.
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From start of radiation therapy to 90 days
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Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy
기간: 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.
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From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.
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Disease-free Survival Rate at 2 Years
기간: From registration to two years
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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.
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From registration to two years
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Overall Survival Rate at 2 Years
기간: From registration to two years
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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.
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From registration to two years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Naresh Jha, MBBS, Cross Cancer Institute at University of Alberta
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2003년 8월 1일
기본 완료 (실제)
2008년 1월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
2003년 9월 10일
QC 기준을 충족하는 최초 제출
2003년 9월 10일
처음 게시됨 (추정)
2003년 9월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 1일
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- RTOG-0244
- CDR0000287213
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