Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

Phase 1

• Conditions: anaplastic glioma; MedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme

• Registration Number: EUCTR2006-001533-17-FR
• Lead Sponsor: EORTC European Organisation for research and treatment of cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

•The combination of :
•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
•Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
•WHO performance status 0-2
•Age = 18 years
•Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
•Start of radiotherapy within 8 days from randomization
•Start of radiotherapy within 7 weeks (49 days) from surgery
•Patients must be on a stable or decreasing dose of steroids for at least two weeks
•No prior chemotherapy (including no treatment with 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 hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days prior to randomization):
•neutrophils greater or equal to 1.5*109 cells/l
•platelets greater or equal to 100*109 cells/l
•bilirubin < 1.5 times upper limit of laboratory normal
•alkaline phosphatase, ASAT and ALAT <2.5 times upper limit of laboratory normal
•serum creatinine lower than 1.5 times upper limit of laboratory normal
•All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
•Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
•Absence of any other serious medical condition that could interfere with follow-up
•Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
•Absence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ of te cervix and non-melanoma skin cancer.
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
•Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Patients can only be randomized in this trial once.

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

Not provided

Study & Design

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