Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Protocol No
ALLIANCE-N0577-CODEL
Principal Investigator
Joseph Bovi
Phase
III
Summary
This research study is a Phase III clinical trial. The purpose of this study is to compare the effectiveness of 1) radiotherapy (RT, radiation therapy) with temozolomide chemotherapy followed by additional temozolomide chemotherapy (RT + TMZ → TMZ); 2) radiotherapy followed by PCV chemotherapy [(RT → PCV); PCV chemotherapy consists of three drugs, Matulane (procarbazine), Lomustine (CCNU) and Oncovin (vincristine)]; and 3) temozolomide chemotherapy alone (TMZ alone) in the treatment of anaplastic glioma, a type of brain tumor. In this study, you will get one of the three possible treatments. This is considered an investigational or research study because the current standard treatment is surgery followed by radiotherapy, not chemotherapy. This treatment research study requires that you have a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing parts of chromosomes are called a tumor marker as they make the tumor distinct from other kinds of tumors. This tumor marker is called the 1p/19q co-deletion. Tumors with this 1p/19q co-deletion typically have a more favorable outcome than other types of anaplastic glioma. Standard therapy at this point in time is surgery followed by radiation therapy. The two main questions this research study will answer are: 1. Do patients survive longer if they are treated with a combination of radiotherapy with temozolomide chemotherapy or radiotherapy with PCV chemotherapy as compared to temozolomide chemotherapy alone? 2. Do patients have a better or worse quality of life and mental function if they are treated with a combination of radiotherapy with temozolomide chemotherapy or radiotherapy with PCV chemotherapy as compared to temozolomide chemotherapy alone?
Description
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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