EUCTR2008-007295-14-NL
Active, not recruiting
Phase 1
Phase III intergroup Study of Radiotherapy versus TemozolomideAlone versus Radiotherapy with concomitant and adjuvantTemozolomide for Patients with 1p/19q Codeleted AnaplasticGlioma. - Codeleted
European Organization for Research and Treatment of Cancer (EORTC)0 sites488 target enrollmentJune 2, 2010
Conditionsewly Diagnosed Anaplastic Glioma with Chromosomal co-deletions of 1p and 19qMedDRA version: 19.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10027744Term: Mixed astrocytoma-oligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10026659Term: Malignant oligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ewly Diagnosed Anaplastic Glioma with Chromosomal co-deletions of 1p and 19q
- Sponsor
- European Organization for Research and Treatment of Cancer (EORTC)
- Enrollment
- 488
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\- \>18 years of age.
- •2\-Newly diagnosed and \=3 months from surgical diagnosis.
- •3\- Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma \[grade 3]), as
- •determined by pre\-registration central pathology review, and tumor is also co\-deleted for 1p and 19q
- •4\- Surgery \=2 weeks prior to registration must have recovered from the effects of
- •5\-Negative pregnancy test done \=7 days prior to registration, for women of
- •childbearing potential only.
- •6\- Willing and able to complete neurocognitive examination without assistance and the QOL by themselves or
- •with assistance (see Section 4\.4\).
- •7\- ECOG performance status (PS) of 0, 1 or 2
Exclusion Criteria
- •1\-Any of the following because this study involves an agent that has knowngenotoxic, mutagenic and teratogenic effects:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •2\-Received any prior surgery, radiotherapy or chemotherapy for any CNS neoplasm (hormones, vitamins and
- •growth factors are not considered chemotherapy for the purposes of this study).
- •3\- Co\-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator,
- •would make the patient inappropriate for entry into this study or interfere significantly with the proper
- •assessment of safety and toxicity of the prescribed regimens.
- •4\- Concomitant serious immuno\-compromised status (other than that related to
Outcomes
Primary Outcomes
Not specified
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