Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02761070 : Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III
PhasePhase 3
AgesMin: 20 Years Max: 75 Years
Eligibility
Inclusion Criteria:

1. Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and
gliosarcoma).

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
lesion.

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
cerebral hemorrhage.

4. No evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and
pituitary gland.

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.

Exclusion Criteria:

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
breast-feeding

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
failure

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
antibodies

17. Gadolinium allergy

18. Positive HIV antibody

19. Positive Hepatitis B (HB)s antigen
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02761070      |      Link to official Clinicaltrials.gov listing
Locations
Fukuoka,
Japan

Facility: Kusyu University Graduate School of Medical Sciences
Investigator:
Contact: Koji Yoshimoto, M.D., Ph.D. Phone: +81-92-642-5524
Click HERE to send email to this center

Hiroshima,
Japan

Facility: Hiroshima University Hospital
Investigator:
Contact: Kazuhiko Sugiyama, M.D. Phone: +81-82-257-5227
Click HERE to send email to this center

Kagoshima,
Japan

Facility: Kagoshima University Graduate School of Medical and Dental Sciences
Investigator:
Contact: Hirofumi Hirano, M.D. Phone: +81-99-275-5111
Click HERE to send email to this center

Kanagawa,
Japan

Facility: Kitasato University School of Medicine
Investigator:
Contact: Toshihiro Kumabe, M.D., Ph.D. Phone: +81-3-3972-8111
Click HERE to send email to this center

Kyoto,
Japan

Facility: Kyoto University Graduate School of Medicine
Investigator:
Contact: Yoshiki Arakawa, M.D. Phone: +81-75-366-7776
Click HERE to send email to this center

Osaka,
Japan

Facility: Osaka International Cancer Institute
Investigator:
Contact: Manabu Kinoshita, M.D. Phone: +81-6-6945-1181
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Sapporo,
Japan

Facility: Nakamura Memorial Hospital
Investigator:
Contact: Kenichi Sato, M.D. Phone: +81-11-231-8555
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Sapporo,
Japan

Facility: Hokkaido University Graduate School of Medicine
Investigator:
Contact: Hiroyuki Kobayashi, M.D. Phone: +81-11-716-1161
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Shizuoka,
Japan

Facility: Shizuoka Canser Center Hospital
Investigator:
Contact: Yoko Nakasu, M.D. Phone: +81-55-989-5222
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Tokyo,
Japan

Facility: National Cancer Center Hospital
Investigator:
Contact: Yoshitaka Narita, M.D., Ph.D. Phone: +81-3-542-2511
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Tokyo,
Japan

Facility: The University of Tokyo Hospital
Investigator:
Contact: Shota Tanaka, M.D. Phone: +81-3-5800-8853
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Tokyo,
Japan

Facility: Keio University Hospital
Investigator:
Contact: Hikaru Sasaki, M.D. Phone: +81-3-3353-1211
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Tokyo,
Japan

Facility: Nihon University School of Medicine Itabashi Hospital
Investigator:
Contact: Atsuo Yoshino, M.D. Phone: +81-3-3972-8111
Click HERE to send email to this center

Tokyo,
Japan

Facility: Kyorin University Faculty of Medicine, Department of Neurosurgery
Investigator:
Contact: Keiichi Kobayashi, M.D., Ph.D. Phone: +81-422-47-5511
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Hirosaki, Aomori
Japan

Facility: Hirosaki University School of Medicine
Investigator:
Contact: Kenichiro Asano, M.D. Phone: +81-172-39-5111
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Shizukawa, Ehime
Japan

Facility: Ehime University Graduate School of Medicine
Investigator:
Contact: Shohei Kouno, M.D. Phone: +81-89-960-5338
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Morioka, Iwate
Japan

Facility: Iwate Medical University
Investigator:
Contact: Takaaki Beppu, M.D. Phone: +81-19-651-5111
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Sendai, Miyagi
Japan

Facility: Tohoku University Graduate School of Medicine
Investigator:
Contact: Masayuki Kanamori, M.D. Phone: +81-22-717-7000
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Hirakata, Osaka
Japan

Facility: Kansai Medical University
Investigator:
Contact: Akio Asai, M.D. Phone: +81-72-804-0101
Click HERE to send email to this center

Suita, Osaka
Japan

Facility: Osaka University Graduate School of Medicine
Investigator:
Contact: Naoki Kagawa, M.D. Phone: +81-6-6879-3652
Click HERE to send email to this center

Hidaka, Saitama
Japan

Facility: Saitama Medical University International Medical Center
Investigator:
Contact: Ryo Nishikawa, M.D., Ph.D. Phone: +81-42-984-4111
Click HERE to send email to this center




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