Efficacy Study of Radiotherapy Alone Versus CCRT With Temozolomide in Grade III Gliomas Without 1p/19q Codeletion

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

1. The management of anaplastic gliomas of WHO grade 3 is currently largely based on surgery followed by radiotherapy, of which prognosis remains still dismal with the median survival of 2-5 years. To date, the benefit of chemo for WHO grade 3 gliomas is unclear of modest at best with conventional cytotoxic agents, and the role of temozolomide for these entities still is not elucidated.

2. Codeletion of chromosome 1p/19q is considered the most important marker of prognostic significance in WHO grade 3 gliomas.

3. To project a randomized phase 2 screening trial examining the efficacy of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3 gliomas without codeletion of chromosome 1p/19q.

4. The prognostic significance of methylation status of MGMT and IDH1 mutation as molecular markers will be also assessed in each arm as key secondary analysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jong Hoon Kim
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion criteria:

• Newly diagnosed histologically proven supratentorial anaplastic gliomas.The histological diagnosis must be obtained from a neurosurgical resection or biopsy of a tumor including an open biopsy or stereotactic biopsy.

• Absence of chromosome 1p/19q co-deletion

• Age 18 years

• Eastern Cooperative Oncology Group performance status of 0-1

• Stable or decreasing dose of steroids for 5 days prior to randomization

• Meets 1 of the following RPA classifications:class III-V

• Adequate hematologic, renal, and hepatic function

• Written informed consent

Exclusion criteria:

• Prior chemotherapy within last 5 years

• Prior radiotherapy of the head and neck area

• Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization

• Planned surgery for other diseases (e.g. dental extraction)

• History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study

• Pregnant or lactating women

• Subject who disagree to follow acceptable methods of contraception

• Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection

• Subject unable to undergo Gd-MRI