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Can a One-Two punch slow recurrent brain cancer?

NCT ID NCT02761070

Disease control Sponsor: Kyorin University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This phase III trial compares two treatment strategies for people whose glioblastoma, an aggressive brain cancer, has returned or progressed after initial therapy. One group receives bevacizumab alone, while the other receives dose-dense temozolomide followed by bevacizumab if the tumor worsens. The study aims to see if the sequential approach improves overall survival compared to bevacizumab alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bevacizumab and temozolomide
What this could lead to
If successful, this could establish a new standard treatment sequence for recurrent glioblastoma, potentially extending survival.
What could go wrong
The trial is in a challenging disease where many treatments fail; benefits may be modest, and both drugs carry risks like bleeding and fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

146 people

The number who actually took part.

Started

Jul 2016

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and gliosarcoma) by WHO2007 criteria. 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 diffuse astrocytoma (Grade II) or anaplastic astrocytoma (Grade III)) 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 immunotherapy (vaccines, immune checkpoint inhibitors, antibodies etc.), bevacizumab (12 weeks or more after termination of prior upfront bevacizumab use) that were combined with TMZ, and intraoperative placement of carmustine wafers, for glioblastoma (including diffuse astrocytoma (Grade II) and anaplastic astrocytoma (Grade III) at onset) diagnosed with WHO2007 criteria. Time periods required from the last day of the prior treatment indicated at registration. ①Peptide vaccination, immune checkpoint inhibitors, antibodies: 4 weeks. ②Bevacizumab: 12 weeks. 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 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

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Conditions

The condition(s) this trial relates to.

Disease Progression glioblastoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma Progression Recurrence

Contacts and locations

Locations

  • Chiba University Hospital

    Chiba, Chiba, 260-8677, Japan

  • Dokkyo Medical University

    Shimotsuge, Tochigi, 321-0293, Japan

  • Ehime University Graduate School of Medicine

    Shizukawa, Ehime, 791-0295, Japan

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192, Japan

  • Hirosaki University School of Medicine

    Hirosaki, Aomori, 036-8563, Japan

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hokkaido University Graduate School of Medicine

    Sapporo, 060-8648, Japan

  • Iwate Medical University

    Morioka, Iwate, 020-8505, Japan

  • Kagoshima University Graduate School of Medical and Dental Sciences

    Kagoshima, 890-8520, Japan

  • Kansai Medical University

    Hirakata, Osaka, 573-1191, Japan

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Kitasato University School of Medicine

    Kanagawa, 252-0374, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556, Japan

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Kusyu University Graduate School of Medical Sciences

    Fukuoka, 812-8582, Japan

  • Kyorin University Faculty of Medicine, Department of Neurosurgery

    Tokyo, 181-8611, Japan

  • Kyoto University Graduate School of Medicine

    Kyoto, 606-8507, Japan

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • Nakamura Memorial Hospital

    Sapporo, 060-8570, Japan

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • Nihon University School of Medicine Itabashi Hospital

    Tokyo, 173-0032, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Osaka University Graduate School of Medicine

    Suita, Osaka, 565-0871, Japan

  • Saga University Hospital

    Saga, Saga-ken, 849-8501, Japan

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298, Japan

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543, Japan

  • Shizuoka Canser Center Hospital

    Shizuoka, 411-8777, Japan

  • The University of Tokyo Hospital

    Tokyo, 113-8655, Japan

  • Tohoku University Graduate School of Medicine

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Medical And Dental University, Medical Hospital

    Bunkyō-Ku, Tokyo, 113-8519, Japan

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576, Japan

  • University of Yamanashi

    Chuo-shi, Yamanashi, 400-8510, Japan

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585, Japan

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