Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/2/2018 |
Start Date: | January 2011 |
End Date: | October 2028 |
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
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.
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.
OBJECTIVES:
Primary
Phase II
- 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.
Phase III
* Compare overall survival rates among patients receiving cisplatin and radiation to those
receiving radiation alone.
Secondary
Phase II/III
- Compare the acute toxicities of these 2 adjuvant treatments.
- Compare late treatment-related adverse events in patients receiving postoperative
radiation to those receiving concurrent chemoradiation.
- Compare progression-free survival rates among patients receiving cisplatin and radiation
to those receiving radiation alone in both the cohort of patients with pathologically
high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma,
salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk
disease (all other eligible diagnoses).
- 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 NRG Oncology 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.
Primary
Phase II
- 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.
Phase III
* Compare overall survival rates among patients receiving cisplatin and radiation to those
receiving radiation alone.
Secondary
Phase II/III
- Compare the acute toxicities of these 2 adjuvant treatments.
- Compare late treatment-related adverse events in patients receiving postoperative
radiation to those receiving concurrent chemoradiation.
- Compare progression-free survival rates among patients receiving cisplatin and radiation
to those receiving radiation alone in both the cohort of patients with pathologically
high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma,
salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk
disease (all other eligible diagnoses).
- 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 NRG Oncology 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.
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
We found this trial at
89
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800 NE 10th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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1201 Camino de Salud Northeast
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Albuquerque, New Mexico 87131
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86 Jonathan Lucas Street
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
Chicago, Illinois 60611
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2010 E 90th St
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2500 N. State St.
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 815-6802
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800 Rose St
Lexington, Kentucky 40536
Lexington, Kentucky 40536
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2220 Pierce Ave
Nashville, Tennessee 37232
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326 Washington Street
Norwich, Connecticut 06360
Norwich, Connecticut 06360
860-892-6936
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Phone: 860-886-8362
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
(407) 648-3800
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Phone: 407-648-3800
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-5830
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2279 45th Street
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Sacramento, California 95817
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1600 Divisadero Street
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161 North Forge Street
Akron, Ohio 44304
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(330) 375-7280
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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800-865-1125
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
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6701 North Charles Street
Baltimore, Maryland 21204
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
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4950 Essen Ln
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
(225) 767-0847
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1055 N Curtis Rd
Boise, Idaho 83706
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(208) 367-2121
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1100 Balsam Ave
Boulder, Colorado 80304
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101 Manning Drive
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
(919) 966-0000
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Cincinnati, Ohio 45267
513-584-7698
Phone: 513-584-9089
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
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11100 Euclid Avenue
Cleveland, Ohio 44106
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216.844.8797
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
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Columbus, Ohio 43210
Phone: 866-627-7616
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2525 S Downing St
Denver, Colorado 80210
Denver, Colorado 80210
(303) 778-1955
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1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
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20 Duke Clinic Cir
Durham, North Carolina 27710
Durham, North Carolina 27710
(888) 275-3853
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Phone: 888-275-3853
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501 E. Hampden Ave.
Englewood, Colorado 80113
Englewood, Colorado 80113
303-788-5000
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Phone: 303-399-8020
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Green Bay, Wisconsin 54301
Phone: 414-433-8184
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Los Angeles, California 90089
Phone: 323-865-0451
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Louisville, Kentucky 40202
Phone: 502-562-4158
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McKee Medical Center Through the years, McKee has led the way in health care innovation....
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Madison, Wisconsin 53792
Phone: 608-262-5223
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3100 Shore Dr.
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
715.735.6621
![Bay Area Cancer Care Center at Bay Area Medical Center](/wp-content/uploads/logos/bay-area-cancer-care-center-at-bay-area-medical-center.gif)
Phone: 414-433-8184
Bay Area Cancer Care Center at Bay Area Medical Center The Bay Area Cancer Care...
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2160 S. First Ave.
Maywood, Illinois 60153
Maywood, Illinois 60153
888-584-7888
![Cardinal Bernardin Cancer Center at Loyola University Medical Center](/wp-content/uploads/logos/cardinal-bernardin-cancer-center-at-loyola-university-medical-center.jpg)
Phone: 708-226-4357
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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9485 Mentor Ave
Mentor, Ohio 44060
Mentor, Ohio 44060
(440) 205-5755
![Lake University Ireland Cancer Center](/wp-content/uploads/logos/lake-university-ireland-cancer-center.jpg)
Phone: 440-205-5755
Lake University Ireland Cancer Center Lake Health is a private, not-for-profit leader in community health...
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-6840
![Medical College of Wisconsin Cancer Center](/wp-content/uploads/logos/medical-college-of-wisconsin-cancer-center.jpg)
Phone: 414-805-4380
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
Newark, Delaware 19713
302-623-4450
![CCOP - Christiana Care Health Services](/wp-content/uploads/logos/ccop---christiana-care-health-services.jpg)
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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Norfolk, Virginia 23507
Phone: 757-388-2406
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8303 Dodge St
Omaha, Nebraska 68114
Omaha, Nebraska 68114
(402) 354-8124
![Methodist Estabrook Cancer Center](/wp-content/uploads/logos/methodist-estabrook-cancer-center.jpg)
Phone: 402-354-5890
Methodist Estabrook Cancer Center At Methodist Estabrook Cancer Center, we understand how deeply a diagnosis...
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111 S 11th St,
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(877) 503-8350
![Kimmel Cancer Center at Thomas Jefferson University - Philadelphia](/wp-content/uploads/logos/kimmel-cancer-center-at-thomas-jefferson-university---philadelphia.jpg)
Phone: 215-955-6084
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
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44405 Woodward Ave
Pontiac, Michigan 48341
Pontiac, Michigan 48341
(248) 858-3000
![St. Joseph Mercy Oakland](/wp-content/uploads/logos/st-joseph-mercy-oakland.jpg)
Phone: 248-858-3612
St. Joseph Mercy Oakland St. Joseph Mercy Oakland (SJMO) is a 443-bed comprehensive, community and...
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2601 Electric Ave
Port Huron, Michigan 48060
Port Huron, Michigan 48060
(810) 985-1500
![Mercy Regional Cancer Center at Mercy Hospital](/wp-content/uploads/logos/mercy-regional-cancer-center-at-mercy-hospital.jpg)
Phone: 810-985-1484
Mercy Regional Cancer Center at Mercy Hospital The Mercy Regional Cancer Center at St. Joseph...
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Portland, Oregon 97239
Phone: 503-494-1080
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4805 NE Glisan St
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
![Providence Cancer Center at Providence Portland Medical Center](/wp-content/uploads/logos/providence-cancer-center-at-providence-portland-medical-center.png)
Phone: 503-215-6412
Providence Cancer Center at Providence Portland Medical Center We strive to give those we serve...
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9205 SW Barnes Rd
Portland, Oregon 97225
Portland, Oregon 97225
(503) 216-1234
![Providence St. Vincent Medical Center](/wp-content/uploads/logos/providence-st-vincent-medical-center.png)
Phone: 503-215-6412
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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353 Fairmont Blvd
Rapid City, South Dakota 57701
Rapid City, South Dakota 57701
(605) 719-1000
![Rapid City Regional Hospital](/wp-content/uploads/logos/rapid-city-regional-hospital.jpg)
Phone: 605-719-2360
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Rockville Centre, New York 11570
Phone: 516-256-3651
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800 S Washington Ave
Saginaw, Michigan 48601
Saginaw, Michigan 48601
(989) 907-8115
![Seton Cancer Institute at Saint Mary's - Saginaw](/wp-content/uploads/logos/seton-cancer-institute-at-saint-mary-s---saginaw.jpg)
Phone: 989-776-8411
Seton Cancer Institute at Saint Mary's - Saginaw At St. Mary's of Michigan, we continue...
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1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-3300
![University of Washington Medical Center](/wp-content/uploads/logos/university-of-washington-medical-center.jpg)
Principal Investigator: Cristina Rodriguez, MD
Phone: 800-804-8824
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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701 N Broadway
Sleepy Hollow, New York 10591
Sleepy Hollow, New York 10591
(914) 366-3000
![Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center](/wp-content/uploads/logos/memorial-sloan-kettering-cancer-center-at-phelps-memorial-hospital-center.jpg)
Phone: 914-366-3000
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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Sparta, New Jersey 07871
Phone: 973-726-4180
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Sturgeon Bay, Wisconsin 54235
Phone: 414-433-8184
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5200 Harroun Rd
Sylvania, Ohio 43560
Sylvania, Ohio 43560
(419) 824-1444
![Flower Hospital Cancer Center](/wp-content/uploads/logos/flower-hospital-cancer-center.gif)
Phone: 419-824-1842
Flower Hospital Cancer Center Established in 1986, ProMedica is a locally owned, nonprofit healthcare organization...
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9191 Grant St
Thornton, Colorado 80229
Thornton, Colorado 80229
(303) 451-7800
![North Suburban Medical Center](/wp-content/uploads/logos/north-suburban-medical-center.jpg)
Phone: 303-399-8020
North Suburban Medical Center North Suburban Medical Center has established a reputation as a facility...
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St. Anne Mercy Hospital Mercy St. Anne Hospital has been providing compassionate, convenient, high-quality inpatient...
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Vancouver, Washington 98684
Phone: 360-944-9889
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Virginia Beach, Virginia 23454
Phone: 757-395-8686
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Voorhees, New Jersey 08043
Phone: 609-261-7074
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100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
(484) 476-2000
![Lankenau Cancer Center at Lankenau Hospital](/wp-content/uploads/logos/lankenau-cancer-center-at-lankenau-hospital.png)
Phone: 610-645-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
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