A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
Principal Investigator
Cristina Rodriguez, MD
Status
Closed to Accrual & Treatment
Date Opened To Accrual
November 03 2010
Date Closed to Accrual
March 08 2021
Disease Site
Head and Neck [HN]
Head and Neck
Phase
II/III
Developmental Therapeutics
No
Primary Objective
Currently accruing to the phase III component:
Phase III: Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Patient Population
Patients with salivary gland carcinomas involving the major (parotid, submandibular, or sublingual glands) and minor salivary glands of the head and neck with the following histologies: intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma; high-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma; high-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma; patients with no evidence of hematogenous metastasis, who have undergone curative intent surgical resection and are found to have the following risk factors for recurrence: T3-4, or N1-3 disease, or T1-2 N0 patients with positive or close (< = 1mm) microscopic margins of resection
Target Accrual
252
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.