RTOG-1008

Closed to Accrual & Treatment

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Protocol Information

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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

Status

Closed to Accrual & Treatment

Open to Accrual

November 3, 2010

Closed to Accrual

March 16, 2015

Open to Accrual

January 25, 2016

Closed to Accrual

March 8, 2021

Closed to Accrual & Treatment

April 22, 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

120

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.