Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
2019年2月1日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
49
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Gainesville、Florida、アメリカ、32610-0232
- University of Florida Shands Cancer Center
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Miami、Florida、アメリカ、33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Illinois
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Springfield、Illinois、アメリカ、62702
- Cancer Institute at St. John's Hospital
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Michigan
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Detroit、Michigan、アメリカ、48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Ohio
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Columbus、Ohio、アメリカ、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、アメリカ、29425
- Hollings Cancer Center at Medical University of South Carolina
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Texas
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Houston、Texas、アメリカ、77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin Cancer Center
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Milwaukee、Wisconsin、アメリカ、53295
- Veterans Affairs Medical Center - Milwaukee
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Alberta
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Edmonton、Alberta、カナダ、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、カナダ、A1B 3V6
- Doctor H. Bliss Murphy Cancer Centre
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Quebec
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Quebec City、Quebec、カナダ、G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
時間枠：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%.
|
At the time of the submandibular salivary gland transfer
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Patients With Acute Xerostomia
時間枠：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).
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From start of treatment to 90 days
|
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Percentage of Patients With Normal Functioning Transferred Submandibular Gland
時間枠：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.
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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
時間枠：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.
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Baseline and one year
|
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Percentage of Patients Experiencing Facial Edema Following Surgery
時間枠：From surgery to 30 days after surgery
|
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
時間枠：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.
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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
時間枠：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
時間枠：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.
|
From registration to two years
|
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Overall Survival Rate at 2 Years
時間枠：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.
|
From registration to two years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Naresh Jha, MBBS、Cross Cancer Institute at University of Alberta
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2003年8月1日
一次修了 (実際)
2008年1月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2003年9月10日
QC基準を満たした最初の提出物
2003年9月10日
最初の投稿 (見積もり)
2003年9月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月5日
QC基準を満たした最後の更新が送信されました
2019年2月1日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RTOG-0244
- CDR0000287213
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。