Astrocytoma, Grade III Clinical Trial
Official title:
A Phase 2, Historically Controlled Study Testing the Efficacy of TTFields (Optune®) With Adjuvant Temozolomide in High Risk WHO Grade II and III Astrocytomas (FORWARD)
This is a phase 2, multi-institutional, historically-controlled, study of 100 patients with newly diagnosed Grade II and III astrocytoma comparing the combination of TTFields with adjuvant temozolomide versus temozolomide alone in historical controls after the completion of definitive chemoradiotherapy. Study treatment may continue past first tumor recurrence. The primary endpoint will be overall survival.
Patients with newly diagnosed high-risk Grade II or III astrocytoma must undergo maximal safe resection (biopsy alone may be eligible) and chemoradiotherapy: concomitant 75mg/m2 daily temozolomide with 80% prescribed dose completed and RT with minimal RT dose of 40 Gy delivered. Within three weeks prior to beginning adjuvant temozolomide, all patients will undergo a Baseline contrast-enhanced MRI of the brain. Within two weeks prior to beginning adjuvant temozolomide, all patients will undergo baseline assessments. Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given. Patients will be seen and examined before each cycle of temozolomide. After a maximum of 12 cycles of adjuvant temozolomide, patients will be seen every 8 weeks. Brain MRI and QoL assessments will be performed every 8 weeks following the baseline MRI for the first 2 years then every 3 months thereafter until second progression (when TTFields treatment will be terminated). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
Active, not recruiting |
NCT03450850 -
Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
|
N/A | |
Completed |
NCT02644291 -
Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors
|
Phase 1 | |
Recruiting |
NCT05765812 -
A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT04757662 -
Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma
|
Phase 1 | |
Not yet recruiting |
NCT06161974 -
Study of Olutasidenib and Temozolomide in HGG
|
Phase 2 | |
Completed |
NCT03224104 -
Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma
|
Phase 1 | |
Terminated |
NCT02722512 -
Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine
|
Phase 1 | |
Recruiting |
NCT06118723 -
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
|
||
Withdrawn |
NCT03956706 -
Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas
|
N/A | |
Recruiting |
NCT03596086 -
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
|
Phase 1/Phase 2 | |
Recruiting |
NCT04304300 -
Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes
|
||
Completed |
NCT03072134 -
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
|
Phase 1 |