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|NCT02761070 : Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III|
|Ages||Min: 20 Years Max: 75 Years|
1. Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and
2. For patients who did not undergo surgery for recurrent disease; pre-registration
contrast MRI should confirm; (i)progressive or recurrent glioblastoma; (ii)no evidence
of acute or subacute cerebral hemorrhage at enrolment; (iii)presence of a measurable
3. For patients who underwent surgery for recurrent disease; (i)progressive or recurrent
glioblastoma must be confirmed on contrast MRI before reoperation; (ii)glioblastoma or
anaplastic astrocytoma must be histologically identified in the tissue resected at
reoperation; (iii)presence of measurable lesions is not mandatory on pre-registration
contrast MRI (more than 4 days after reoperation); (iv)no MRI evidence of aggravating
4. No evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and
5. No evidence of meningeal dissemination or gliomatosis cerebri.
6. Prior treatment for newly-diagnosed glioblastoma (or anaplastic astrocytoma) with
postoperative TMZ administered concomitantly with radiotherapy (>=54 Gy for <=69 years
old; >=30 Gy for >=70 years old) and at least for two cycles (5/28d) as an adjuvant
treatment have been given.
7. No history of prior treatment with stereotactic radiotherapy (ex.
Gamma-knife/Cyberknife), proton beam irradiation, neutron capture therapy, and
chemotherapies except standard dose TMZ and intraoperative placement of carmustine
wafers for .glioblastoma.
8. More than 90 days after completion of radiotherapy. For those who underwent
reoperation, between 21 and 28 days postoperatively.
9. Age between 20 and 75 years at enrolment.
10. Karnofsky Performance Status >= 60 within 14 days before enrolment.
11. No prior treatment with chemotherapy, molecular targeted therapy, or radiotherapy to
head and neck area for other malignancies.
12. Adequate organ function.
13. Written informed consent.
1. Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ
or mucosal tumors curatively treated with local therapy
2. Active infection requiring systemic therapy
3. Body temperature >= 38 degrees Celsius at registration
4. Women during pregnancy, possible pregnancy, within 28 days after delivery, or
5. Psychosis or with psychotic symptom
6. Continuous systemic use of immunosuppressant except for steroid
7. Uncontrolled diabetes mellitus or routine administration of insulin
8. Unstable angina within 3 weeks, with a history of myocardial infarction within 6
months, or New York Heart Association (NYHA) class II or greater congestive heart
9. Inadequately controlled hypertension (cannot be controlled to a systolic pressure of
>= 150 mmHg and a diastolic pressure of >= 100 mmHg)
10. History of symptomatic cerebrovascular disorder (including subarachnoid hemorrhage,
cerebral infarction and transient ischemic attack) within 6 months or history of
vascular disorder requiring intervention (including venous/arterial thrombosis or
embolism and aortic aneurysm) within 6 moths
11. History of grade >= 2 hemoptysis within 28 days
12. History of hemorrhagic tendency (e.g., coagulation disorder) or any grade >= 3
hemorrhage within 28 days
13. History of gastrointestinal perforation, fistula, abdominal abscess or uncontrolled
peptic ulcer within 6 months
14. Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema
15. Severe non-healing wound or traumatic fracture at enrolment
16. Hypersensitivity to Chinese Hamster Ovary-derived drugs or other recombinant
17. Gadolinium allergy
18. Positive HIV antibody
19. Positive Hepatitis B (HB)s antigen
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02761070
| Link to official Clinicaltrials.gov listing