EUCTR2008-007295-14-AT
Active, not recruiting
Phase 1
Phase III intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with concomitant and adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma. - Codeleted
DrugsTEMODAL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- 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
- •8\- Provide informed written consent.
- •9\- Patient willing to provide tissue samples for research purposes
Exclusion Criteria
- •1\-Any of the following because this study involves an agent that has known
- •genotoxic, 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
- •concomitant steroids).
- •5\- Active uncontrolled systemic infection or HIV.
Outcomes
Primary Outcomes
Not specified
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Phase III intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with concomitant and adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma. - Codeletedewly Diagnosed Anaplastic Glioma with Chromosomal co-deletions of 1p and 19qMedDRA version: 12.1Level: LLTClassification code 10065443Term: Malignant gliomaMedDRA version: 12.1Level: LLTClassification code 10026659Term: Malignant oligodendrogliomaMedDRA version: 12.1Level: LLTClassification code 10002224Term: Anaplastic astrocytomaMedDRA version: 12.1Level: LLTClassification code 10027744Term: Mixed astrocytoma-oligodendrogliomaEUCTR2008-007295-14-BEEORTC488
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Phase 2
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