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

NCT00068237 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG-0244CDR0000287213
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 12

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.

Conditions

Head and Neck Cancer; Radiation Toxicity; Xerostomia

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

Outcome Measures

Primary Outcomes (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%.

  At the time of the submandibular salivary gland transfer

Secondary Outcomes (8)

• Percentage of Patients With Acute Xerostomia

  From start of treatment to 90 days

• Percentage of Patients With Normal Functioning Transferred Submandibular Gland

  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

  Baseline and one year

• Percentage of Patients Experiencing Facial Edema 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

  From start of radiation therapy to 90 days

Study Arms (1)

Surgery + Transfer + Radiation

EXPERIMENTAL

Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.

Procedure: salivary gland transfer; Radiation: Post-operative radiation therapy

Interventions

salivary gland transfer 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

Surgery + Transfer + Radiation

Post-operative radiation therapy RADIATION

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

Surgery + Transfer + Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

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

Columbus, Ohio, 43210-1240, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Doctor H. Bliss Murphy Cancer Centre

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

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 22541957 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries; Xerostomia; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: Radiation Therapy Oncology Group (RTOG)

wseiferheld@acr.org

Study Officials

• Naresh Jha, MBBS

  Cross Cancer Institute at University of Alberta

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: August 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2016
• Last Updated: February 5, 2019
• Results First Posted: January 31, 2014

Record last verified: 2019-01

Locations

CA (3); US (9)