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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

From randomization to 2 years.

Safety Issue:

No

Principal Investigator

Cristina P. Rodriguez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

RTOG 1008

NCT ID:

NCT01220583

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms
  • Salivary Gland Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Swedish Medical CenterEnglewood, Colorado  80110
North Suburban Medical CenterThornton, Colorado  80229
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
UMDNJ University HospitalNewark, New Jersey  07103
Lake/University Ireland Cancer CenterMentor, Ohio  44060
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
McKee Medical CenterLoveland, Colorado  80539
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Highland Hospital of RochesterRochester, New York  14620
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
William W. Backus HospitalNorwich, Connecticut  06360
Cancer Treatment CenterWooster, Ohio  44691
Stanford Cancer CenterStanford, California  94305-5824
McFarland Clinic, PCAmes, Iowa  50010
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Frederick R. and Betty M. Smith Cancer Treatment CenterSparta, New Jersey  07871
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Duke Cancer InstituteDurham, North Carolina  27710
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Cancer Care Center, IncorporatedSalem, Ohio  44460
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Rocky Mountain Cancer Centers - AuroraAurora, Colorado  80012
Door County Cancer Center at Door County Memorial HospitalSturgeon Bay, Wisconsin  54235-1495
Coastal Cancer Center at Sentara Virginia Beach General HospitalVirginia Beach, Virginia  23454
Memorial Sloan-Kettering Cancer Center - Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center - Rockville CentreRockville Centre, New York  11570