A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Tx & IMRT Tomo to Reduce Xerostomia

This study is currently recruiting participants.

Verified by Alberta Cancer Board, July 2007

First Received: July 3, 2007 No Changes Posted

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00497406

Purpose

A study for head and neck cancer patients to evaluate the feasibility of combining salivary gland transfer surgical procedure and IMRT helical tomotherapy to reduce dryness of mouth.

Condition	Intervention
Head and Neck Cancer	Procedure: Salivary gland transfer Procedure: Tomotherapy treatment

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy Salivary Gland Disorders Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Transfer Procedure and Intensity Modulated Radiation Therapy (Helical Tomotherapy) to Reduce Dryness of Mouth (Xerostomia) in Head and Neck Cancer Patients After Surgery

Further study details as provided by Alberta Cancer Board:

Estimated Enrollment:	12
Study Start Date:	December 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologically-proven newly-diagnosed squamous cell carcinoma of oropharynx, larynx, hypopharynx and unknown primary of cancer with neck node metastasis after primary surgery
AJCC stage I-IV patients are eligible provided they are MO and NO-2b
18 years of age or older
KPS of 70 or greater

Exclusion Criteria:

N3/N2C disease or M1 disease
salivary gland disease i.e. Sjogren's syndrome
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
prior radiotherapy to the head and neck region
lymph node involvement (level I-III) or proximity of disease to submandibular gland on the side chosen for salivary gland transfer on frozen section or permanent pathological evaluation
pre-epiglottic space involvement on pathological examination
involvement of level I nodes on either side of neck
post-op recurrent disease at presentation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497406

Contacts

Contact: Christy Bartoshewski, RN	780-577-8029	cgray@cancerboard.ab.ca
Contact: Michelle Encarnacao, RN	780-432-8234	michenca@cancerboard.ab.ca

Locations

Canada, Alberta
Cross Cancer Institute	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Tammy Mah-Fraser, MS 780-577-8047 tammymah@cancerboard.ab.ca
Sub-Investigator: Naresh Jha, MD, FRCPC
Sub-Investigator: Matthew Parliament, MD, FRCPC

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Study Chair:

Rufus Scrimger, MD, FRCPC

Alberta Cancer Board

More Information

No publications provided

Study ID Numbers:	HN-4-0027
Study First Received:	July 3, 2007
Last Updated:	July 3, 2007
ClinicalTrials.gov Identifier:	NCT00497406 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

submandibular salivary gland transfer
intensity-modulated radiation therapy
helical tomotherapy
reduction of xerostomia

Study placed in the following topic categories:

Mouth Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Salivary Gland Diseases
Xerostomia

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

Stomatognathic Diseases
Salivary Gland Diseases
Xerostomia

ClinicalTrials.gov processed this record on May 07, 2009