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: 20.0Level: 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-NL
• 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: 2007-04-18
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 751

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 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 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 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
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

REGISTRATION:
- Previous 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