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Temozolomide Challenge After Progressive disease

Temozolomide Challenge After Progressive disease - TCAP study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000014688
Enrollment
39
Registered
2014-07-29
Start date
2008-11-01
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

None listed

Sponsors

Department of Neurosurgery Ehime University Graduated School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed malignant glioma 2)18 Years and older 3)Karnofsky performance status >/= 50% 4)no previous chemotherapy and radiotherapy 5)Patients who have undergone recent therapy recurrent or progressive tumor are eligible provided that a minimum of 28 days must have elapsed from the day of prior therapy 6)To have a proper organ function 7)Under the management responsibility of the study (sharing) doctor, contraception during the study is possible regardless of gender. 8)Laboratory values ​​that were carried out before registration began meet one of the following criteria:. Clinical test item standard Neutrophil count (real) >/= 1,500 / mm3 Platelet count >/= 100,000 / mm3 Serum creatinine 1.5mg/dL or less

Exclusion criteria

Exclusion criteria: 1)Patients with a history of hypersensitivity to dacarbazine or temozolomide. 2)Patients who are contraindicated to chemotherapeutic agents other than temozolomide. 3)The patient in need of surgery, additional radiotherapy to the PD after determination 4)Pregnant or lactating women 5)Double cancer of activity 6)It is complicated by pneumonia or meningitis in need of treatment. 7)Has been complicated by psychiatric symptoms or psychosis, it is determined that participation in the research is difficult. 8)patients have been complicated by uncontrolled diabetes. 9)patients have unstable angina or a history of myocardial infarction within 3 months. 10)And has a history of interstitial pneumonia or pulmonary fibrosis,. 11)When used interferon beta preparation maintenance therapy by temozolomide, patients corresponding to the following items are excluded.

Design outcomes

Primary

MeasureTime frame
1)KPS, 2)survival time from PD, 3)adverse event

Countries

Japan

Contacts

Public ContactShohei Kohono

Ehime University Graduated School of Medicine neurosurgery

kouno@m.ehime-u.ac.jp089-960-5338

Outcome results

None listed

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