Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01220583
First received: October 12, 2010
Last updated: March 17, 2015
Last verified: March 2015
  Purpose

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 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.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years [ Time Frame: From randomization to 2 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) rate at 2 years [ Time Frame: From randomization to 2 years. ] [ Designated as safety issue: No ]
  • PFS rate at 5 years [ Time Frame: From randomization to 5 years. ] [ Designated as safety issue: No ]
  • OS rate at 5 years [ Time Frame: From randomization to 5 years. ] [ Designated as safety issue: No ]
  • Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment [ Time Frame: From start of treatment to last follow-up. ] [ Designated as safety issue: Yes ]
  • Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment [ Time Frame: From start of treatment to 30 days after the end of treatment. ] [ Designated as safety issue: Yes ]
  • Chemotherapy delivery as measured by percentage of protocol prescription given [ Time Frame: From start of treatment to end of treatment. ] [ Designated as safety issue: No ]
  • Radiation delivery as measured by elapsed treatment days [ Time Frame: From start of treatment to end of treatment. ] [ Designated as safety issue: No ]
  • Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy. [ Time Frame: From randomization to 2 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: cisplatin
Given IV
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Undergo radiotherapy
Experimental: Arm II
Patients undergo 3D-CRT or IMRT as in arm I.
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Undergo radiotherapy

Detailed Description:

OBJECTIVES:

Primary

  • Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.
  • Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Secondary

  • Compare the acute toxicities of these 2 adjuvant treatments.
  • Compare long-term efficacy results at 5 years and late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.
  • Investigate quality of life and patient-reported outcomes in patients enrolled in the study.
  • Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.
  • Establish a Radiation Therapy Oncology Group (RTOG) baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms.

  • 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.
  • Arm II: Patients undergo 3D-CRT or IMRT as in arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes:

    • High-grade mucoepidermoid carcinoma
    • Salivary duct carcinoma
    • High-grade adenocarcinoma
  • 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 patients with salivary gland malignancies originating from the minor salivary glands
  • No patients with histologies other than high-grade mucoepidermoid carcinoma, high-grade adenocarcinoma, or salivary duct carcinoma

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220583

  Hide Study Locations
Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
University of California Davis Cancer Center
Sacramento, California, United States, 95817
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80110
McKee Medical Center
Loveland, Colorado, United States, 80539
North Suburban Medical Center
Thornton, Colorado, United States, 80229
United States, Connecticut
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Indiana
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States, 21204
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
Memorial Sloan-Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States, 07920
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States, 11725
Beth Israel Medical Center - Petrie Division
New York, New York, United States, 10003-3803
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center - Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States, 98684
United States, Wisconsin
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States, 54235-1495
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Saudi Arabia
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology
Investigators
Principal Investigator: Cristina P. Rodriguez, MD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01220583     History of Changes
Other Study ID Numbers: RTOG 1008, CDR0000686072, NCI-2013-00370
Study First Received: October 12, 2010
Last Updated: March 17, 2015
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
high-grade salivary gland mucoepidermoid carcinoma
salivary gland adenocarcinoma
stage IVA salivary gland cancer
stage IVB salivary gland cancer
stage IVC salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Salivary Gland Neoplasms
Mouth Diseases
Mouth Neoplasms
Neoplasms
Neoplasms by Site
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 01, 2015