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

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?