RTOG 0537 Protocol Information

A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia---RTOG CCOP Study
Principal Investigator: Raimond K. W. Wong, MD
Primary Objective:

Phase II component-Determine the feasibility of successfully delivering the ALTENS treatment (given with the Codetron® unit) in a cooperative group setting

Phase III component-Determine whether the ALTENS treatment reduces overall xerostomia burden, as measured by the University of Michigan 15-item Xerostomia-Related Quality of Life Scale (XeQOLS), compared to the pilocarpine treatment at 9 months from randomization

Patient Population:

Patients who have completed radiotherapy (standard or IMRT) +/- chemotherapy for head and neck cancers and who have grade 1-2 xerostomia according to the CTCAE v. 3.0 dry mouth/salivary gland xerostomia scale


Target Accrual Phase II: 45

Target Accrual Phase III: 144

Target Accrual: 189
Current Accrual: 196
Status: Terminated
Date: 11/17/2014
Participating Sites:
Adventist Medical Center Portland OR
AnMed Health Cancer Center Anderson SC
Bixby Medical Center Adrian MI
Boston Medical Center MBCCOP Boston MA
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
Case Western Reserve University Cleveland OH
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec
CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec
Cleveland Clinic Foundation Cleveland OH
Compass Oncology Vancouver Vancouver WA
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Flower Hospital Sylvania OH
Goshen Center for Cancer Care Goshen IN
Gundersen Lutheran Medical Center La Crosse WI
Indiana University Health Bloomington Bloomington IN
Indiana University Health Methodist Hospital Indianapolis IN
John H Stroger Jr Hospital of Cook County Chicago IL
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario
Lima Memorial Hospital Lima OH
McGill University Department of Oncology Montreal
Medical University of Ohio Toledo OH
Mercy Hospital Saint Louis St Louis MO
Mercy Saint Anne Hospital Toledo OH
Methodist Hospital Philadelphia PA
Moffitt Cancer Center Tampa FL
North Coast Cancer Care Sandusky OH
PeaceHealth Southwest Medical Center Vancouver WA
Providence Milwaukie Hospital Milwaukie OR
Providence Portland Medical Center Portland OR
Providence Saint Vincent Medical Center Portland OR
Rapid City Regional Hospital Rapid City SD
Rochester General Hospital Rochester NY
Roswell Park Cancer Institute Buffalo NY
Saint Charles Hospital Oregon OH
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Vincent Mercy Medical Center Toledo OH
Spartanburg Medical Center Spartanburg SC
St. Anthony's Health Alton IL
The Research Institute of the McGill University Health Centr Montreal
Thomas Jefferson University Hospital Philadelphia PA
Toledo Clinic Cancer Centers-Adrian Adrian MI
Toledo Clinic Cancer Centers-Maumee Maumee OH
Toledo Community Hospital Oncology Program CCOP Toledo OH
UCSF Medical Center-Mount Zion San Francisco CA
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Virginia Cancer Center Charlottesville VA
Upstate Carolina CCOP Spartanburg SC
Western Oncology Research Consortium Portland OR
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Yale-New Haven Hospital Saint Raphael Campus New Haven CT
Updated: 11/17/2014

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