Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON intergroup trial. - ND

Phase 1

• Conditions: newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis; MedDRA version: 9.1 Level: LLT Classification code 10018338 Term: Glioma

• Registration Number: EUCTR2006-001533-17-IT
• Lead Sponsor: E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 748

Inclusion Criteria

Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review. Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression WHO performance status 0-2 Age ≥ 18 years All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding Before patient registration, written informed consent must be obtained, according to ICH/GCP, and national/local regulations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

known HIV infection, chronic hepatitis B or hepatitis C infection any other serious medical condition that can interfere with follow-up any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction) previous or concurrent malignancies at other sites with the exception 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; those conditions should be discussed with the patient before registration in the trial prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel) prior radiotherapy to the brain

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma;Secondary Objective: To assess whether concurrent and adjuvant temozolomide treatment prolongs progression free survival and neurological deterioration free survival in patients with non-1p/19q deleted anaplastic glioma. To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition. To assess the impact of concurrent and adjuvant temozolomide treatment on the quality of life in patients with non-1p/19q deleted anaplastic glioma.;Primary end point(s): The primary endpoint of the study is overall survival, as measured from the day of randomization.