JCOG1910: A Randomized Phase III Study of Chemoradiotherapy in Elderly Patients with Newly Diagnosed Glioblastoma

JRCT ID: jRCTs031200099

Registered date:27/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: glioblastoma
• Date of first enrollment: 04/09/2020
• Target sample size: 264
• Study type: Interventional

Intervention(s)

Arm A:
(1) 40 Gy in 15 daily fractions with temozolomide
(i) Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (2.67 Gy/day, 5 days/week, 15 times and 40 Gy in total)
(ii) Maintenance phase, temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles

Arm B:
(1) 25 Gy in 5 daily fractions with temozolomide
(i) Concomitant phase, temozolomide (150 mg/m2, 5 days from first day), radiation (5 Gy/day, 5 days/week, 5 times and 25 Gy in total)
(ii) Maintenance phase, temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, Proportion of adverse events, Proportion of Karnofsky Performance Status (KPS) preservation, Proportion of Health-related Quality of Life (QOL) preservation

Key inclusion & exclusion criteria

• Age minimum: >= 71age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

First registration criteria
(1) Diagnosed as glioblastoma or Grade III glioma (WHO 2016 edition) in pathological diagnosis during surgery, or histologically proven diagnosis of glioblastoma by WHO 2016 criteria.
(2) Tumor specimen is available to analyze MGMT promoter methylation.
(3) No history of treatments for glioma except for resection including biopsy and the second resection within 21 days after the first resection (partly resection or biopsy).
(4) Within 21 days after surgery.
(5) The tumor exists supratentorial region on preoperative head contrast MRI.
(6) Preoperative head contrast MRI revealed no dissemination.
(7) Presence of measurable lesions is not mandatory.
(8) Patient' s age is 71 years or older at registration. Aged 71 to 75 years old with resection of less than 90% of contrast region.
(9) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor.
(10) No prior chemotherapy or head radiation therapy for any intracranial tumors.
(11) 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 =< 1.605 mg/dL (male), =< 1.185 mg/dL (female)
(12) Written informed consent.

Second registration criteria
(1) Within 21 days of the first registration
(2) Histologically proven diagnosis of glioblastoma by WHO 2016 edition.
(3) Judged as methylation or unmethylation in MGMT promoter region.

Exclude criteria

(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) Severe psychological disease.
(5) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor.
(6) Uncontrollable diabetes mellitus.
(7) Unstable angina pectoris, or history of myocardial infarction within 6 months.
(8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p.
(9) Gadolinium allergy.
(10) Positive HIV antibody.
(11) Positive HBs antigen.

Related Information

• Primary Sponsor: ARAKAWA Yoshiki
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development