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Phase II Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Chemotherapy in Patients With Resected High-Risk Malignant Salivary Gland Tumors

Status
Active
Cancer Type
Oral Cancer
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01220583
Protocol IDs
RTOG-1008 (primary)
RTOG-1008
Study Sponsor
Radiation Therapy Oncology Group

Summary

Rationale

Radiation therapy(RAY-dee-AY-shun THAYR-uh-pee)

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
uses high-energy x-rays(EX-ray)

A type of high-energy radiation. In low doses, x-rays are used to diagnose diseases by making pictures of the inside of the body. In high doses, x-rays are used to treat cancer.
to kill tumor(TOO-mer)

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancer), or malignant (cancer). Also called neoplasm.
cells.(sel)

The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.
DrugsAny substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic. used in chemotherapy,(KEE-moh-THAYR-uh-pee)

Treatment with drugs that kill cancer cells.
such as cisplatin,(sis-PLA-tin)

A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent.
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(SER-juh-ree)

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
in treating salivary gland(SA-lih-VAYR-ee gland)

A gland in the mouth that produces saliva.
tumors.

Purpose

This randomized(RAN-duh-mized KLIH-nih-kul TRY-ul)

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
phase II trialA study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer. is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant(muh-LIG-nunt)

Cancerous. Malignant cells can invade and destroy nearby tissue and spread to other parts of the body.
salivary glandAn organ that makes one or more substances, such as hormones, digestive juices, sweat, tears, saliva, or milk. Endocrine glands release the substances directly into the bloodstream. Exocrine glands release the substances into a duct or opening to the inside or outside of the body. tumors that have been removed by surgery.

Objectives

Primary

  1. Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.
  2. Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Secondary

  1. Compare the acute toxicities of these 2 adjuvant treatments.
  2. Compare long-term efficacy results at 5 years and late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.
  3. Investigate quality of life and patient-reported outcomes in patients enrolled in the study.
  4. Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.
  5. Establish an RTOG baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Greg Johnstone
404-778-4206

Doctors:

Jonathan J. Beitler MD, MBA, FACR
Suresh S. Ramalingam MD
Dong Moon Shin MD
Taofeek K. Owonikoko MD
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