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Multicombination Therapy of Temozolomide, Vincristine, and Interferon-beta with Radiotherapy for Malignant Glioma

Multicombination Therapy of Temozolomide, Vincristine, and Interferon-beta with Radiotherapy for Malignant Glioma - R-TVI trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040599
Enrollment
50
Registered
2020-05-31
Start date
2008-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant glioma

Interventions

Initial therapy: Temozolomide (75mg/m2/day), Day 1 to 45, po Vincristine (0.6mg/m2), Day2 and 3, iv IFN-beta (3MIU/body/day), 3 days/week, DIV, during radiotherapy Radiotherapy (60 Gy/30 fr), 5 d

Sponsors

Department of Neurosurgery, Hirosaki University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) For patients who undergo surgery for first relapse disease with histologically proven malignant glioma and could accept informed consent 2) Age is 16~80 yo 3) Tumor location is in supra-tentorial lesion without optic nerve, hypothalamus, brain stem and dissemination 4) Without experience of chemo-radiotherapy for other malignant tumor 5) Without past history of RT 6) Without double cancer 7) Eastern Cooperative Oncology Group(ECOG) performance scale(PS) 0-2 or PS3 with neurological deficit 8) With normal organic function 9) Without severe infection 10) This protocol would be able to start within 21 days 11) The rate of operation removal is not concern

Exclusion criteria

Exclusion criteria: Patients who did not satisfy inclusion criteria

Design outcomes

Primary

MeasureTime frame
2y-OS

Secondary

MeasureTime frame
Progression free survival: PFS 5y-OS Overall survival: OS PFS and OS with MGMT methylation status Adverse event

Countries

Japan

Contacts

Public ContactKenichiro Asano

Hirosaki University School of Medicine Department of Neurosurgery

asanoken@hirosaki-u.ac.jp0172-39-5115

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026