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Alliance N0577

Trial

Clinical Trial Title

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

Trial Status

Open to Enrollment

Start Date

April 3, 2020

Trial Type

Cancer - Adult Oncology

Specific Condition

Brain disease

Description

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, 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 giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Eligibility Criteria

Eligibility Criteria

  • Central pathology review submission
  •  This review is mandatory prior to registration to confirm eligibility. Patients must be willing to submit tissue samples for mandatory central pathology review submission. It should be initiated as soon after surgery as possible.
  • Tissue must have been determined to have local 1p/19q co-deletion and IDH mutation prior to submission for central path review.
  •  Tumor tissue must show co-deletion of chromosomes 1p and 19q.
  •  Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses.
  • Age ≥ 18 years of age.
  • Newly diagnosed and ≤ 3 months from surgical diagnosis. Patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy.
  • Histological evidence of WHO grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study.
  • Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration
  • Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • ECOG performance status (PS) of 0, 1 or 2

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:56 PM