JCOG1016: Phase III randomized study for anaplastic glioma of radiotherapy with temozolomide vs. ACNU followed by temozolomide

JRCT ID: jRCTs031180215

Registered date:08/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: anaplastic glioma
• Date of first enrollment: 09/07/2014
• Target sample size: 280
• Study type: Interventional

Intervention(s)

[A]
(I) first-line therapy
(i) concomitant phase: temozolomide (75 mg/m2, everyday from first day to last day of radiation)+radiation (60 Gy/30 fr, 5 days/week)
(ii) maintainance phase: temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles
(II) second-line therapy (after pregression/recurrence): best physician's choice
[B]
(I) first-line therapy
(i) concomitant phase: ACNU (80 mg/m2, day1 and day36 of radiation)+radiation (60 Gy/30 fr, 5 days/week)
(ii) maintainance phase: ACNU (80 mg/m2, day1 every 8 weeks) 6 cycles
(II) second-line therapy (after progression/recurrence): temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, Complete response rate, Response rate, Adverse events, Serious adverse events, Proportion of completion of first-line therapy

Key inclusion & exclusion criteria

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

Include criteria

(1) Histologically proven anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma) or anaplastic ganglioglioma. For those who had additional surgery, he or she must meet (a) or (b).
(a) Diagnosed with anaplastic glioma after both primary and additional surgeries.
(b) Even if diagnosed with low grade glioma after primary surgery, diagnosed with anaplastic glioma after additional surgery.
(2) No history of previous therapy for tumor except craniotomy or biopsy (newly diagnosed tumor). Those who underwent additional surgery within 84 days after primary surgery are eligible.
(3) No history of carmustine implant or photodynamic therapy during the surgery.
(4) No clinically systemic metastasis (Imaging study except chest X-ray is not mandatory).
(5) More than 50% of tumor existing cerebrum and diencephalon.
(6) Preoperative MRI revealed no tumor recognized in the optic nerve, olfactory nerve and pituitary gland.
(7) Preoperative MRI revealed no multiple legions or dissemination.
(8) Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume under consultation with radiation oncologist.
(9) Preoperative and postoperative MRI revealed measurable or non-measurable disease.
(10) Three to 20 days after surgery.
(11) Aged 20 to 69 years old at registration.
(12) ECOG performance status (PS) of 0, 1, 2 or 3 due to neurological signs caused by the tumor.
(13) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is accepted.
(14) Adequate organ function.
(15) Tests for mutation of R132H on IDH1 gene by immunohistochemistry or PCR method is performed either from resected or biopsy samples.
(16) 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 requiring treatment
(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) Uncontrolled diabetes mellitus or routine administration of insulin
(8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
(9) Interstitial pneumonia, fibroid lung, or severe lung emphysema
(10) Gadolinium allergy
(11) Positive HIV antibody
(12) Potitive HBs antigen

Related Information

• Primary Sponsor: MURAGAKI Yoshihiro
• 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): UMIN000014104