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NRG RTOG-1008

Status:

Recruiting | Phase II and III

Official Title:

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

Study Purpose:

To compared the effects of radiation and chemotherapy with radiation alone on patients with salivary gland cancer that was removed surgically to find out which is better at reducing the risk of the cancer coming back.

Interventions:

  • Radiation Therapy
  • Study agents: Cisplatin
  • Quality of Life questionnaires
  • ARM 1: Radiation with Cisplatin IV given every week for seven weeks
  • ARM 2: Radiation for about 7 weeks.
    After completion of study therapy, patients are followed for as long as the study is active.   

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older


Diagnosis:

Salivary gland cancer that has been surgically removed.  Cell Types: Intermediate or high grade Adenocarcinoma.  Intermediate or high grade mucoepidermoid carcinoma.  High grade salivary duct carcinoma.  High grade acinic cell carcinoma.  High grade adenoid cystic carcinoma


Eligibility:

Subjects must have had their cancer surgically removed.

Subjects must not have received any other treatment for their cancer

Subjects must not have any significant pre-existing hearing loss.

Subjects must not have any evidence of metastatic disease.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

NRG RTOG-1008

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!