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

NCT ID: NCT00068237

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2016-12-31

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 and then annually.

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

Conditions

Head and Neck Cancer; Radiation Toxicity; Xerostomia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

salivary gland transfer

Intervention Type: PROCEDURE

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 therapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naresh Jha, MBBS

Role: STUDY_CHAIR

Cross Cancer Institute at University of Alberta

Locations

University of Florida Shands Cancer Center

Gainesville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

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

Columbus, Ohio, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, United States

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, Canada

Doctor H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 22541957 (View on PubMed)

Other Identifiers

CDR0000287213

Identifier Type: -

Identifier Source: secondary_id

RTOG-0244

Identifier Type: -

Identifier Source: org_study_id