JCOG1016: Phase III randomized study for anaplastic glioma of radiotherapy with temozolomide vs. ACNU followed by temozolomide
- Conditions
- anaplastic glioma
- Registration Number
- JPRN-jRCTs031180215
- Lead Sponsor
- MURAGAKI Yoshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
(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.
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival, Complete response rate, Response rate, Adverse events, Serious adverse events, Proportion of completion of first-line therapy