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

Active, not recruiting

• Conditions: Anaplastic glioma; MedDRA version: 16.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-11
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

AT REGISTRATION :
• 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
• WHO performance status 0-2
• Age = 18 years
• All patients must use effective contraception id 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 can 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 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.
RANDOMIZATION:
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 (extra 2 days could be allowed).
•Patients must be on a stable or decreasing dose of steroids for at least two weeks.
•Adequate hematological, renal and hepatic function.
•All patients, must use effective contreception 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.

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 748
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

•Privious other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to registration; and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix.
•Prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®)
• Prior radiotherapy to the brain
RANDOMIZATION:
• 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