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/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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

More Details

Status
Recruiting
Sponsor
Radiation Therapy Oncology Group

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.