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

1 februari 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

49

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Florida
      • Gainesville, Florida, Förenta staterna, 32610-0232
        • University of Florida Shands Cancer Center
      • Miami, Florida, Förenta staterna, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
    • Illinois
      • Springfield, Illinois, Förenta staterna, 62702
        • Cancer Institute at St. John's Hospital
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Texas
      • Houston, Texas, Förenta staterna, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Förenta staterna, 53295
        • Veterans Affairs Medical Center - Milwaukee
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Quebec
      • Quebec City, Quebec, Kanada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: salivary gland transfer
Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1
Strålning: Post-operative radiation therapy
Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients With Acute Xerostomia
Tidsram: 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
Tidsram: 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.
Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
Tidsram: 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
Percentage of Patients Experiencing Facial Edema Following Surgery
Tidsram: From surgery to 30 days after surgery
Facial edema was noted as present or absent following surgery.
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Radiation Therapy Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Naresh Jha, MBBS, Cross Cancer Institute at University of Alberta

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2003

Primärt slutförande (Faktisk)

1 januari 2008

Avslutad studie (Faktisk)

1 december 2016

Studieregistreringsdatum

Först inskickad

10 september 2003

Först inskickad som uppfyllde QC-kriterierna

10 september 2003

Första postat (Uppskatta)

11 september 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 februari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 februari 2019

Senast verifierad

1 januari 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RTOG-0244
  • CDR0000287213

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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