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JCOG1703: A multicenter randomized phase III study for newly-diagnosed maximally resected glioblastoma comparing Carmustine wafer implantation followed by chemoradiotherapy with temozolomide with chemoradiotherapy alone (MACS)

JCOG1703: A multicenter randomized phase III study for newly-diagnosed maximally resected glioblastoma comparing Carmustine wafer implantation followed by chemoradiotherapy with temozolomide with chemoradiotherapy alone (MACS)

KUMABE Toshihiro

Kitasato University Hospital

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

kuma@kitasato-u.ac.jp

KUMABE Toshihiro

Kitasato University Hospital

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

+81-42-778-8111

kuma@kitasato-u.ac.jp

Not Recruiting

June. 03, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Suspicious as the primary glioblastoma on preoperative head contrast MRI.
(2) Judged that resection of more than 90% of contrast region on head contrast MRI can be achieved.
(3) No history of resection including biopsy for glioma. In case who diagnosed as glioblastoma after the first resection (partly resection or biopsy), all of the following conditions must be fulfilled:
(i) Resection of more than 90% of contrast region will be performed at the institutions in JCOG study groups of the Brain Tumor Study Group within 3 weeks from the first resection.
(ii) Preoperative head contrast MRI before first resection is available.
(iii) Negative of immunostaining of IDH1 if performed.
(4) The tumor exists in the cerebrum and diencephalon on preoperative head contrast MRI and no evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and pituitary gland.
(5) Preoperative head contrast MRI revealed no multiple legions or dissemination.
(6) Aged 20 to 75 years old at registration.
(7) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor.
(8) No prior chemotherapy or head radiation therapy for any malignant diseases
(9) Sufficient organ function.
(i) Neutrophil count >= 1,500 /mm3
(ii) Hemoglobin >= 8.0 mg/dl
(iii) Platelet count >= 100,000 /mm3
(iv) AST =< 120 U/L
(v) ALT =< 120 U/L
(vi) Cr =< 1.5 mg/dL
(10) Written informed consent.

Second registration (intraoperative) criteria
(1) Within 14 days of the first registration
(2) Diagnosed as glioblastoma or Grade III glioma (WHO 2016 edition) in pathological diagnosis during surgery.
(3) Judged as achievement of resection of more than 90% of the tumor. Intra MRI is not mandatory.

(1) Synchronous or metachronous (within 2 years) malignancies
(2) Infections which needs systemic treatment.
(3) Body temperature is higher than 38 degrees centigrade at registration.
(4) Female during pregnancy, within 28 days of postparturition, or during lactation.
(5) Severe psychological disease.
(6) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor.
(7) Uncontrollable diabetes mellitus.
(8) Unstable angina pectoris, or history of myocardial infarction within 6 months.
(9) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p.
(10) Gadolinium allergy.
(11) Positive HIV antibody.
(12) Positive HBs antigen.

Both

glioblastoma

Arm A:
(1) Resection
(2) Chemoradiotherapy with tmozolomide (Stupp resimen)
(i) Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (60 Gy/30 fr, 5 days/week)
(ii) Maintenance phase, temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles

Arm B:
(1) Resection
(2) Carmustine wafer implantation up to 8
(3) Chemoradiotherapy with tmozolomide (Stupp resimen)
(i) Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (60 Gy/30 fr, 6 days/week)
(ii) Maintenance phase, temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles

Overall survival

Progression-free survival, Loco-regional progression-free survival, Proportion of adverse events

+81-3-3542-2511

April. 03, 2019

none