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Head and Neck CancerPhase 2NCT00068237

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

A Phase 2 study testing salivary gland transfer and Post-operative radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Radiation Therapy Oncology Group at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
salivary gland transfer and Post-operative radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
12 sitesin 2 countries
Study dates
Aug 2003to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States9 sites

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

Other trials in United States

Canada3 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

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.

Being tested
salivary gland transfer, Post-operative radiation therapy
Keywords
xerostomia, radiation toxicity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, untreated metastatic squamous neck cancer with occult primary, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the oropharynx
Medical subject headings
Head and Neck Neoplasms, Radiation Injuries, Xerostomia, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • salivary gland transferProcedure or surgery

    Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1

  • Post-operative radiation therapyRadiation

    Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.

Study groups in NCT00068237
Study groupRoleWhat they receive
Surgery + Transfer + RadiationExperimentalSubmandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Receives: Procedure: salivary gland transfer; Radiation: Post-operative radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"

    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%.

    Measured: At the time of the submandibular salivary gland transfer

Secondary outcomes (8)

  1. Percentage of Patients With Acute Xerostomia

    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).

    Measured: From start of treatment to 90 days

  2. Percentage of Patients With Normal Functioning Transferred Submandibular Gland

    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.

    Measured: Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)

  3. Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire

    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.

    Measured: Baseline and one year

  4. Percentage of Patients Experiencing Facial Edema Following Surgery

    Facial edema was noted as present or absent following surgery.

    Measured: From surgery to 30 days after surgery

  5. Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy

    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.

    Measured: From start of radiation therapy to 90 days

  6. Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy

    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.

    Measured: From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.

  7. Disease-free Survival Rate at 2 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.

    Measured: From registration to two years

  8. Overall Survival Rate at 2 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.

    Measured: From registration to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionJan 2008
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068237
Sponsor's protocol ID
RTOG-0244
Other IDs
CDR0000287213
Status last verified
Jan 2019
First submitted
10 Sep 2003
Last updated
5 Feb 2019
Data monitoring committee
Yes

Publications

  • Jha N, Harris J, Seikaly H, Jacobs JR, McEwan AJ, Robbins KT, Grecula J, Sharma AK, Ang KK. A phase II study of submandibular gland transfer prior to radiation for prevention of radiation-induced xerostomia in head-and-neck cancer (RTOG 0244). Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):437-42. doi: 10.1016/j.ijrobp.2012.02.034. Epub 2012 Apr 27.

    PubMed 22541957

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing salivary gland transfer and Post-operative radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Radiation Therapy Oncology Group at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" (time frame: At the time of the submandibular salivary gland transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00068237, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.

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