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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.
  • Sponsor: Radiation Therapy Oncology Group

    Current Primary Outcome: 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. ]

    Original Primary Outcome: 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

    Current Secondary Outcome:

    • Overall survival (OS) rate at 2 years [ Time Frame: From randomization to 2 years. ]
    • PFS rate at 5 years [ Time Frame: From randomization to 5 years. ]
    • OS rate at 5 years [ Time Frame: From randomization to 5 years. ]
    • 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. ]
    • 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. ]
    • Chemotherapy delivery as measured by percentage of protocol prescription given [ Time Frame: From start of treatment to end of treatment. ]
    • Radiation delivery as measured by elapsed treatment days [ Time Frame: From start of treatment to end of treatment. ]
    • 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. ]


    Original Secondary Outcome:

    • Overall survival (OS) rate at 2 years
    • PFS rate at 5 years
    • OS rate at 5 years
    • 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
    • Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment
    • Chemotherapy delivery as measured by percentage of protocol prescription given
    • Radiation delivery as measured by elapsed treatment days
    • 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 ...


    Information By: Radiation Therapy Oncology Group

    Dates:
    Date Received: October 12, 2010
    Date Started: January 2011
    Date Completion:
    Last Updated: April 24, 2017
    Last Verified: April 2017