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 currently recruiting participants.
Verified December 2013 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01220583
First received: October 12, 2010
Last updated: December 16, 2013
Last verified: December 2013

October 12, 2010
December 16, 2013
January 2011
August 2016   (final data collection date for primary 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 [ Time Frame: From randomization to 2 years. ] [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01220583 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall survival (OS) rate at 2 years [ Designated as safety issue: No ]
  • PFS rate at 5 years [ Designated as safety issue: No ]
  • OS rate at 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 [ Designated as safety issue: Yes ]
  • Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment [ Designated as safety issue: Yes ]
  • Chemotherapy delivery as measured by percentage of protocol prescription given [ Designated as safety issue: No ]
  • Radiation delivery as measured by elapsed treatment days [ Designated as safety issue: No ]
  • Determine whether quality of life, fatigue, and xerostomia as measured by the FACT-H&N subscale, PSS-HN, PROMIS-fatigue short form, the XeQOLS, and the EQ-5D respectively, differ as a function of treatment assignment at 3, 12, and 24 months after com ... [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
A Randomized Phase II 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 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

  • 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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: cisplatin
    Given IV
  • Radiation: 3-dimensional conformal radiation therapy
    Undergo radiotherapy
  • Radiation: intensity-modulated radiation therapy
    Undergo radiotherapy
  • 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.
    Interventions:
    • Drug: cisplatin
    • Radiation: 3-dimensional conformal radiation therapy
    • Radiation: intensity-modulated radiation therapy
  • Experimental: Arm II
    Patients undergo 3D-CRT or IMRT as in arm I.
    Interventions:
    • Radiation: 3-dimensional conformal radiation therapy
    • Radiation: intensity-modulated radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States,   Canada,   Saudi Arabia
 
NCT01220583
RTOG 1008, CDR0000686072, NCI-2013-00370
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Cristina P. Rodriguez, MD OHSU Knight Cancer Institute
Radiation Therapy Oncology Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP