Clinical Trial of the Week: Treatment study for patients who have had malignant salivary gland tumors removed

By Donna Loyle, communications specialist, LIMR

Researchers seek to determine if patients who have had malignant salivary gland tumors surgically removed can benefit from three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) plus cisplatin vs. radiation therapy alone.

This is a randomized phase II/phase III study of adjuvant concurrent radiation and chemotherapy vs. radiation alone in resected high-risk malignant salivary gland tumors.

Eligible patients must have pathologically proven diagnosis of a malignant major salivary gland tumor of one of the following histologic subtypes:

  • high-grade mucoepidermoid carcinoma
  • salivary duct carcinoma
  • high-grade adenocarcinoma

Inclusion criteria:

  • Must have had surgical resection (removal or partial removal) of malignant salivary glands within eight weeks before trial registration
  • Must have a medical oncology evaluation within four weeks before trial registration
  • Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin
  • Must be free of distant metastases based upon the following minimum diagnostic workup: radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration

Additional criteria may apply.

This trial is available at Bryn Mawr Hospital, Lankenau Medical Center and Paoli Hospital. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more on trial RTOG 1008, visit https://www.mainlinehealth.org/research/clinical-trials/rtog-1008

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