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

Tracking Information

First Received Date ^ICMJE

September 10, 2003

Last Updated Date

May 9, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Reproducibility

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00068237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of acute xerostomia
Salivary scan evaluation
Quality of life
Toxicity
Disease-free survival
Overall survival

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

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.

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.

PROJECTED ACCRUAL: A total of 11-48 patients will be accrued for this study within 1.6 years.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Open Label

Condition ^ICMJE

Head and Neck Cancer
Radiation Toxicity
Xerostomia

Intervention ^ICMJE

Drug: radioprotection
Procedure: conventional surgery
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

18 to 80

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00068237

Responsible Party

Study ID Numbers ^ICMJE

CDR0000287213, RTOG-0244

Study Sponsor ^ICMJE

Radiation Therapy Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Jha Naresh, MBBS

Cross Cancer Institute at University of Alberta

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP