NL-OMON48284CompletedPhase 3
IDH mutated 1p/19q intact lower grade glioma following resection: Wait Or Treat? IWOT - A phase III study - IWOT
European Organisation for Research in Treatment of Cancer (EORTC)0 sites127 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 127
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Histologically WHO grade II (diffuse) or III (anaplastic) astrocytoma, IDHmt
- •without 1p/19q co-deletion (local diagnosis)
- •At the time of randomization presence only of a non-enhancing tumor on T1
- •weighted contrast enhanced MR
- •images; some faint non-nodular enhancement or enhancement that can be ascribed
- •to the surgical resection or
- •peri-operative ischemia is allowed. Preoperative enhancement is allowed
- •provided this area is resected as shown on postoperative imaging.
- •Time since diagnostic surgery or first resection <= 6 months
- •No need for immediate radiotherapy followed by chemotherapy
- •Functional deficits due to the resection is allowed
- •Patients for whom by local judgment an active surveillance policy is a
- •realistic management alternative
- •Adults >= 18years of age
- •WHO PS 0-2
- •Adequate hematological, renal, and hepatic function
- •Presence of at least one paraffin block from the initial diagnosis for
- •pathology review and translational research. If a representative FFPE block is
- •not available, the collection of optimally 36, minimally 24 x 5 µm, unstained
- •slides is required.
- •Ability to take oral medication
- •Written informed consent
Exclusion Criteria
- •Presence of signs of increased intracranial pressure after surgery
- •Requirement of steroids for control of tumor symptoms
- •Presence of uncontrolled seizures after surgery
- •Functional deficits due to the tumor
- •Presence of contra-indications for radiotherapy
- •Hypersensitivity to dacarbazine (DTIC), to the active substance or to any of
- •the excipients used for TMZ capsules
- •Prior chemotherapy, or prior radiotherapy to the brain
- •Known HIV, chronic hepatitis B, or hepatitis C infection
- •Inability to take oral medication (e.g., frequent vomiting, partial bowel
- •obstruction)
- •Concurrent severe or uncontrolled medical disease
- •Not pregnant, agree to use adequate birth control measures, no breast feeding
- •Prior or second invasive malignancy, with some defined exceptions
- •Presence of any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up
Investigators
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