JCOG1303:Randomized phase III study for unresectable WHO Grade II diffuse astrocytoma with radiotherapy alone or chemoradiotherapy with temozolomide

JRCT ID: jRCTs031180201

Registered date:07/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: WHO Grade II diffuse astrocytoma
• Date of first enrollment: 01/09/2014
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Arm A: Radiotherapy alone (50.4 Gy/28 fr, 5 days/week)
Arm B: Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (50.4 Gy/28 fr, 5 days/week)
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, Response rate, Complete response rate, Completion of therapy , Adverse events, Serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

1) Histologically proven Grade II astrocytoma by WHO2016 classification. A large single tumor extending 3 lobes is included when it is histologically diagnosed as grade II astrocytoma.
For those who had additional surgery, he/she must meet a) or b).
a) diagnosed with Grade II astrocytoma after both primary and addtional surgeries by WHO2016 classification.
b) undiagnosed after ptimary surgery and diagnosed with Grade II astrocytoma after additional surgery by WHO2016 classification.
2) No history of previous therapy for tumor except resection or biopsy.
3) No clinically systemic metastasis (Imaging study except chest X-ray is not mandatory).
4) 50% or more of the tumor existing in the cerebrum and diencephalon on preoperative MRI.
5) Postoperative MRI within 42 days after surgery revealed residual tumor and the extension of removal of the tumor by volumetric method shows either (A) or (B).
(A) Tumor resection < 90%
(B) Tumor resection >=90% and <100%, and classified as high risk by EORTC low grade glioma score
*EORTC LGG score high risk includes at least three of the following conditions.
(1) age >= 40 years
(2) largest diameter of the tumor >= 60 mm
(3) tumor crossing the midline
(4) astrocytoma histology subtype
(5) presence of neurologic deficit
6) Preoperative MRI revealed no multiple legions or dissemination.
7) Preoperative and postoperative MRI revealed measurable or non-measurable disease.
8) Three to 42 days after surgery.
9) Aged 20 to 69 years old at registration.
10) KPS(Karnofsky performance status)of 70-100.
11) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is acceptable.
12) Adequate organ function.
Sufficient organ function.
i. Neutrophil >= 1,500/mm3
ii. Hb >= 8.0 g/dL
iii. Platelet >= 100,000/mm3
iv. AST <= 120 IU/L
v. ALT <= 120 IU/L
vi. Creatinine <= 1.5 mg/dL
13) Written informed consent.

Exclude 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) Active infectious meningitis
4) Body temperature >= 38 degrees Celsius at registration
5) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
6) Psychosis or with psychotic symptom
7) Continuous systemic use of steroid or immunosuppressant for disease except for brain tumor
8) Uncontrolled diabetes mellitus or routine administration of insulin
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
10) Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema diagnosed with X-ray test
11) Gadolinium allergy
12) Positive HIV antibody
13) Potitive HBs antigen

Related Information

• Primary Sponsor: NARITA Yoshitaka
• Secondary Sponsor: MIYAKITA Yasuji
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000014578