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Clinical Trials/NL-OMON44004
NL-OMON44004
Completed
Phase 3

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

European Organisation for Research in Treatment of Cancer (EORTC)0 sites54 target enrollmentTBD
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Conditionsanaplastic oligodendroglial tumors10029211

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
anaplastic oligodendroglial tumors
Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)
Enrollment
54
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)

Eligibility Criteria

Inclusion Criteria

  • •\* Provide informed written consent.
  • •\* Patient willing to provide tissue samples for deletion status
  • •\* \*18 years of age.
  • •\* Newly diagnosed and \<3 months from surgical diagnosis.
  • •\* Histological confirmation of anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma (grade 3\-4\)
  • •\* Loss of heterozygosity for both 1p and 19q (\*co\-deletion\*).
  • •\* \*2 weeks from the date of surgery and must have recovered from the effects of surgery
  • •\* Adequate hematological, renal and liver function
  • •\* Negative pregnancy test (B\-HCG) done \*7 days prior to registration, for women of childbearing potential only.
  • •\* Willing and able to complete neurocognitive/QOL questionnaire(s) by themselves or with assistance

Exclusion Criteria

  • •\* For women: not pregnant or nursing, for all patients of childbearing potential: willing to employ adequate contraception
  • •\* No prior surgery, radiotherapy or chemotherapy for any CNS neoplasm
  • •\* No co\-morbid systemic illnesses or other severe concurrent disease which, would interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • •\* No concomitant serious immuno\-compromised status (other than that related to concomitant steroids).
  • •\* No active uncontrolled systemic infection or HIV.
  • •\* Not receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • •\* No active other malignancy, excepting non\-melanotic skin cancer or carcinoma\-in\-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
  • •\* No history of myocardial infarction \*6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life\-threatening ventricular arrhythmias.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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