A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

Who is this study for? Adult patients with salivary gland tumors
Status: Active, not recruiting
Location: See all (268) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• DISEASE CHARACTERISTICS:

• Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:

• Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma

• High-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma

• Surgical resection with curative intent within 8 weeks prior to registration

• All patients must have a Medical Oncology evaluation within 4 weeks prior to registration

• Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup:

• History/physical examination within 8 weeks prior to registration

• Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable)

• No patients with residual macroscopic disease after surgery

• No prior systemic chemotherapy or radiation therapy for salivary gland malignancy

• PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3

• Platelets ≥ 100,000 cells/mm^3

• Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)

• Serum creatinine < 2.0 mg/dL

• Total bilirubin < 2 x the institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN

• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential

• Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment

• Not pregnant or nursing

• Patients must be deemed able to comply with the treatment plan and follow-up schedule

• Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review

• No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

• No severe, active co-morbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

• Transmural myocardial infarction within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol)

• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol)

• Protocol-specific requirements may also exclude immunocompromised patients

• Pre-existing ≥ grade 2 neuropathy

• No significant pre-existing hearing loss, as defined by the patient or treating physician

• PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable)

• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

• No prior organ transplant

• No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy

• No concurrent erythropoiesis-stimulating agents

Locations
United States
Alabama
The Kirklin Clinic at Acton Road
Birmingham
University of Alabama at Birmingham Cancer Center
Birmingham
Arizona
Arizona Breast Cancer Specialists-Gilbert
Gilbert
Arizona Center for Cancer Care-Peoria
Peoria
Arizona Breast Cancer Specialists-Phoenix
Phoenix
Arizona Oncology-Deer Valley Center
Phoenix
Cancer Center at Saint Joseph's
Phoenix
Arizona Breast Cancer Specialists
Scottsdale
Arizona Breast Cancer Specialists-Scottsdale
Scottsdale
Arizona Oncology Services Foundation
Scottsdale
Arizona Center for Cancer Care-Surprise
Surprise
Banner University Medical Center - Tucson
Tucson
University of Arizona Cancer Center-North Campus
Tucson
University of Arizona Cancer Center-Orange Grove Campus
Tucson
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
Mills-Peninsula Medical Center
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Mercy San Juan Medical Center
Carmichael
City of Hope Comprehensive Cancer Center
Duarte
UC San Diego Moores Cancer Center
La Jolla
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Fremont - Rideout Cancer Center
Marysville
Memorial Medical Center
Modesto
Hoag Memorial Hospital
Newport Beach
Saint Joseph Hospital - Orange
Orange
Stanford Cancer Institute Palo Alto
Palo Alto
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
UCSF Medical Center-Mission Bay
San Francisco
UCSF Medical Center-Mount Zion
San Francisco
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
University of Colorado Hospital
Aurora
Boulder Community Hospital
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
Porter Adventist Hospital
Denver
Swedish Medical Center
Englewood
Rocky Mountain Cancer Centers-Littleton
Littleton
Longmont United Hospital
Longmont
McKee Medical Center
Loveland
North Suburban Medical Center
Thornton
Rocky Mountain Cancer Centers-Thornton
Thornton
Connecticut
William Backus Hospital
Norwich
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Helen F Graham Cancer Center
Newark
Beebe Health Campus
Rehoboth Beach
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
University of Florida Health Science Center - Gainesville
Gainesville
Baptist MD Anderson Cancer Center
Jacksonville
University of Florida Health Science Center - Jacksonville
Jacksonville
Miami Cancer Institute
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Orlando Health Cancer Institute
Orlando
Moffitt Cancer Center
Tampa
Georgia
Emory Proton Therapy Center
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Memorial Health University Medical Center
Savannah
Iowa
McFarland Clinic PC - Ames
Ames
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Siouxland Regional Cancer Center
Sioux City
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Loyola University Medical Center
Maywood
Saint John's Hospital
Springfield
Indiana
IU Health North Hospital
Carmel
Goshen Center for Cancer Care
Goshen
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Sidney and Lois Eskenazi Hospital
Indianapolis
Memorial Hospital of South Bend
South Bend
Kansas
University of Kansas Cancer Center
Kansas City
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
The James Graham Brown Cancer Center at University of Louisville
Louisville
Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge
Ochsner Medical Center Jefferson
New Orleans
Touro Infirmary
New Orleans
University Medical Center New Orleans
New Orleans
Massachusetts
Boston Medical Center
Boston
Maryland
Greater Baltimore Medical Center
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Michigan
Bixby Medical Center
Adrian
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Ascension Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Weisberg Cancer Treatment Center
Farmington Hills
Genesys Hurley Cancer Institute
Flint
West Michigan Cancer Center
Kalamazoo
Saint Mary Mercy Hospital
Livonia
Saint Joseph Mercy Oakland
Pontiac
Lake Huron Medical Center
Port Huron
Ascension Saint Mary's Hospital
Saginaw
Saint John Macomb-Oakland Hospital
Warren
Henry Ford West Bloomfield Hospital
West Bloomfield
Minnesota
Mayo Clinic in Rochester
Rochester
Missouri
University of Missouri - Ellis Fischel
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Freeman Health System
Joplin
Delbert Day Cancer Institute at PCRMC
Rolla
Siteman Cancer Center-South County
Saint Louis
SSM Health Saint Louis University Hospital
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Mercy Hospital Springfield
Springfield
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Billings Clinic Cancer Center
Billings
Bozeman Deaconess Hospital
Bozeman
Kalispell Regional Medical Center
Kalispell
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Duke University Medical Center
Durham
Nebraska
Alegent Health Bergan Mercy Medical Center
Omaha
Nebraska Methodist Hospital
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Memorial Sloan Kettering Monmouth
Middletown
Memorial Sloan Kettering Bergen
Montvale
Virtua Memorial
Mount Holly
Rutgers New Jersey Medical School
Newark
Sparta Cancer Treatment Center
Sparta
Virtua Voorhees
Voorhees
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
New York
Northwell Health Imbert Cancer Center
Bay Shore
Maimonides Medical Center
Brooklyn
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Northwell Health/Center for Advanced Medicine
Lake Success
Long Island Jewish Medical Center
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Lenox Hill Hospital
New York
Memorial Sloan Kettering Cancer Center
New York
Mount Sinai Chelsea
New York
Mount Sinai Hospital
New York
Mount Sinai Union Square
New York
Highland Hospital
Rochester
University of Rochester
Rochester
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow
State University of New York Upstate Medical University
Syracuse
Memorial Sloan Kettering Nassau
Uniondale
Ohio
Summa Health System - Akron Campus
Akron
Summa Health System - Barberton Campus
Barberton
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Foundation
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Mercy Cancer Center-Elyria
Elyria
Summa Health Medina Medical Center
Medina
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights
University Hospitals Parma Medical Center
Parma
UH Seidman Cancer Center at Salem Regional Medical Center
Salem
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky
ProMedica Flower Hospital
Sylvania
Mercy Health - Saint Anne Hospital
Toledo
University of Toledo
Toledo
University of Cincinnati Cancer Center-West Chester
West Chester
Cancer Treatment Center
Wooster
Oklahoma
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
Clackamas
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Bryn Mawr Hospital
Bryn Mawr
Geisinger Medical Center
Danville
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg
Penn State Milton S Hershey Medical Center
Hershey
Geisinger Medical Oncology-Lewisburg
Lewisburg
Lewistown Hospital
Lewistown
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon
UPMC Jameson
New Castle
Paoli Memorial Hospital
Paoli
Fox Chase Cancer Center
Philadelphia
Temple University Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
UPMC Jefferson Regional Radiation Oncology
Pittsburgh
UPMC-Passavant Hospital
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
Lankenau Medical Center
Wynnewood
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
South Dakota
Rapid City Regional Hospital
Rapid City
Tennessee
University of Tennessee - Knoxville
Knoxville
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
MD Anderson in The Woodlands
Conroe
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
M D Anderson Cancer Center
Houston
MD Anderson West Houston
Houston
MD Anderson League City
League City
MD Anderson in Sugar Land
Sugar Land
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork
Sandra L Maxwell Cancer Center
Cedar City
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
Utah Valley Regional Medical Center
Provo
Dixie Medical Center Regional Cancer Center
Saint George
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
Inova Schar Cancer Institute
Fairfax
Inova Fairfax Hospital
Falls Church
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton
Sentara Norfolk General Hospital
Norfolk
Sentara Virginia Beach General Hospital
Virginia Beach
Vermont
Norris Cotton Cancer Center-North
Saint Johnsbury
Washington
Saint Francis Hospital
Federal Way
Seattle Cancer Care Alliance at Northwest Hospital
Seattle
University of Washington Medical Center - Montlake
Seattle
Compass Oncology Vancouver
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Aurora Health Center-Fond du Lac
Fond Du Lac
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Green Bay Oncology at Saint Vincent Hospital
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
University of Wisconsin Hospital and Clinics
Madison
Aurora Bay Area Medical Group-Marinette
Marinette
Bay Area Medical Center
Marinette
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Medical College of Wisconsin
Milwaukee
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids
West Virginia
West Virginia University Healthcare
Morgantown
Wheeling Hospital/Schiffler Cancer Center
Wheeling
Other Locations
Canada
Cross Cancer Institute
Edmonton
London Regional Cancer Program
London
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal
CHUM - Hopital Notre-Dame
Montreal
McGill University Department of Oncology
Montreal
The Research Institute of the McGill University Health Centre (MUHC)
Montreal
Health Sciences North
Sudbury
University Health Network-Princess Margaret Hospital
Toronto
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Riyadh
Time Frame
Start Date: January 2011
Estimated Completion Date: October 2028
Participants
Target number of participants: 252
Treatments
Experimental: Arm I
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
Experimental: Arm II
Patients undergo 3D-CRT or IMRT as in arm I.
Related Therapeutic Areas
Sponsors
Leads: Radiation Therapy Oncology Group
Collaborators: NRG Oncology, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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