Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
1. Februar 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
49
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Alberta
-
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
-
-
Quebec
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Quebec City, Quebec, Kanada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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-
-
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Florida
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Gainesville, Florida, Vereinigte Staaten, 32610-0232
- University of Florida Shands Cancer Center
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Miami, Florida, Vereinigte Staaten, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
-
-
Illinois
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Springfield, Illinois, Vereinigte Staaten, 62702
- Cancer Institute at St. John's Hospital
-
-
Michigan
-
Detroit, Michigan, Vereinigte Staaten, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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-
Ohio
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Columbus, Ohio, Vereinigte Staaten, 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, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
-
Texas
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Houston, Texas, Vereinigte Staaten, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
-
Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Vereinigte Staaten, 53295
- Veterans Affairs Medical Center - Milwaukee
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Patients With Acute Xerostomia
Zeitfenster: 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).
|
From start of treatment to 90 days
|
|
Percentage of Patients With Normal Functioning Transferred Submandibular Gland
Zeitfenster: 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
Zeitfenster: 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.
|
Baseline and one year
|
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Percentage of Patients Experiencing Facial Edema Following Surgery
Zeitfenster: 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
|
|
Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy
Zeitfenster: 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.
|
From start of radiation therapy to 90 days
|
|
Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy
Zeitfenster: 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.
|
From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.
|
|
Disease-free Survival Rate at 2 Years
Zeitfenster: 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
|
|
Overall Survival Rate at 2 Years
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Naresh Jha, MBBS, Cross Cancer Institute at University of Alberta
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2003
Primärer Abschluss (Tatsächlich)
1. Januar 2008
Studienabschluss (Tatsächlich)
1. Dezember 2016
Studienanmeldedaten
Zuerst eingereicht
10. September 2003
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. September 2003
Zuerst gepostet (Schätzen)
11. September 2003
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Februar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Februar 2019
Zuletzt verifiziert
1. Januar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- unbehandelter metastasierter Plattenepithelkarzinom mit okkultem Primärtumor
- Plattenepithelkarzinom des Oropharynx im Stadium III
- Plattenepithelkarzinom des Oropharynx im Stadium IV
- Plattenepithelkarzinom im Stadium III des Hypopharynx
- Plattenepithelkarzinom des Hypopharynx im Stadium IV
- Plattenepithelkarzinom des Kehlkopfes im Stadium III
- Plattenepithelkarzinom des Kehlkopfes im Stadium IV
- Strahlentoxizität
- Plattenepithelkarzinom des Hypopharynx im Stadium I
- Stadium II Plattenepithelkarzinom des Hypopharynx
- Plattenepithelkarzinom im Stadium II des Oropharynx
- Xerostomie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RTOG-0244
- CDR0000287213
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