A randomised phase III Trial on concurrent and adjuvant Temozolomide chemotherapy in non 1p/19q deleted anaplastic glioma to evaluate overall survival.

Phase 3

Completed

• Conditions: Anaplastic Glioma; Neurological - Other neurological disorders; Cancer - Other cancer types

• Registration Number: ACTRN12609000485235
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Study Completion: 2024-08-27
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis AND absence of combined 1p/19q loss. Both of which must have been determined by either local testing or central review.

Newly diagnosed disease

Prior surgery for a low grade tumour is allowed, provided histological confirmation of an anaplastic tumour is present at the time of progression.

Tumour material available for central 1p/19q assessment, central O6-methylguanine-DNAmethyltransferase promotor methylation status assessment and central pathology review.

Patients must be on a stable or decreasing dose of steroids for at lease 2 weeks prior to ransomisation.

WHO performance status 0-2

Start of radiotherapy within 8 days of randomisation

Start of radiotherapy within 7 weeks of (49 days) of surgery

No prior chemotherapy (including no treatment with Carmustine or bis-chloronitrosourea (BCNU) containing wafers (Gliadel)

No prior radiotherapy to the brain

No concomitant treatment with other anti-cancer agents or with any other experimental agent

Adequate renal, haematological and hepatic function according to all the following laboratory values (to be performed within 14 days prior to randomisation):
Neutrophils > or = 1.5*1000000000 cells/l
Platelets > or = 100*1000000000 cells/l
Bilirubin<1.5 times upper limit of laboratory normal

Alkaline phosphatase, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 2.5 times upperlimit for laboratory normal

Exclusion Criteria

Pregnant or breast feeding

Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C infection.

Any medical condition that could interfere with follow-up, oral medication intake (eg. frequent vomiting, partial bowel obstruction)

Previous concurrent malignancies at other sites with the exemption of surgically cured carcinoma in situ of the cervix and non-melanoma skin cancer.

Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival[ From the day of randomisation to death due to any cause. Patients would have three monthly disease and status assessment after the end of radiotherapy until death or when the last analysis is planned. Patients not reported dead or lost to follow up will be censored at the date of the last examination.]