Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
1. února 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
49
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alberta
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Edmonton, Alberta, Kanada, 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, Kanada, A1B 3V6
- Doctor H. Bliss Murphy Cancer Centre
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Quebec
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Quebec City, Quebec, Kanada, G1R 2J6
- Centre Hospitalier Universitaire de Québec
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Florida
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Gainesville, Florida, Spojené státy, 32610-0232
- University of Florida Shands Cancer Center
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Miami, Florida, Spojené státy, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Illinois
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Springfield, Illinois, Spojené státy, 62702
- Cancer Institute at St. John's Hospital
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Michigan
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Detroit, Michigan, Spojené státy, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Ohio
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Columbus, Ohio, Spojené státy, 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, Spojené státy, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Texas
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Houston, Texas, Spojené státy, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Spojené státy, 53295
- Veterans Affairs Medical Center - Milwaukee
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
Časové okno: 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%.
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At the time of the submandibular salivary gland transfer
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Patients With Acute Xerostomia
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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From registration to two years
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Naresh Jha, MBBS, Cross Cancer Institute at University of Alberta
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2003
Primární dokončení (Aktuální)
1. ledna 2008
Dokončení studie (Aktuální)
1. prosince 2016
Termíny zápisu do studia
První předloženo
10. září 2003
První předloženo, které splnilo kritéria kontroly kvality
10. září 2003
První zveřejněno (Odhad)
11. září 2003
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. února 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. února 2019
Naposledy ověřeno
1. ledna 2019
Více informací
Termíny související s touto studií
Klíčová slova
- neléčený metastatický skvamózní karcinom krku s okultní primární
- spinocelulárního karcinomu orofaryngu stadia III
- dlaždicobuněčného karcinomu orofaryngu stadia IV
- spinocelulární karcinom hypofaryngu stadia III
- skvamocelulární karcinom hypofaryngu stadia IV
- spinocelulárního karcinomu hrtanu stadia III
- dlaždicobuněčný karcinom hrtanu stadia IV
- radiační toxicita
- I. stadium spinocelulárního karcinomu hypofaryngu
- spinocelulární karcinom hypofaryngu stadia II
- stadium II spinocelulárního karcinomu orofaryngu
- xerostomie
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RTOG-0244
- CDR0000287213
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .