A Clinical Study of Standard TEMODAL® Regimen Versus Standard Regimen Plus Early Post-Surgery TEMODAL® Chemotherapy in Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Inclusion Criteria:
Only the patients who meet all these criteria can be enrolled in the study:
- Patients with prior histological confirmation of newly diagnosed primary glioblastoma
multiforme in supratentorial cerebral hemisphere.
- Gross total resection or partial resection (imaging) >70%.
- At least be capable to obtain a tissue sample for MGMT analysis during surgery.
- Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.
- Age >=18 and <=70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Life expectancy >=9 months.
- Laboratory test values must satisfy the following criteria:
- absolute neutrophil count >=1.5 x 10^9/L;
- platelet count >=100 x 10^9/L;
- hemoglobin >=80 g/L;
- blood urea nitrogen and creatinine < 1.5 x upper limit of normal value (ULN);
- total bilirubin and direct bilirubin < 1.5 x ULN;
- alanine aminotransferase and aspartate aminotransferase < 3 x ULN;
- alkaline phosphatase < 2 x ULN.
- Patients must be willing to provide written informed consent.
- Patients of child-bearing potential (including female subjects and the female
partners of male subjects) must use an effective method of contraception.
Exclusion Criteria:
Patients will not be enrolled if any of the following criteria apply:
- Patient with previous or current malignancies (except melanoma) at other sites,
unless disease free for at least 3 years.
- Patient who received chemotherapy, radiotherapy for study indication, or other
medications for antitumor indication prior to surgery.
- Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri).
- Patient with metastatic lesions at the subtentorial or outside of calvaria.
- Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor.
- Patient who received radiotherapy at head or neck which leads to radiotherapy domain
overlapping.
- Patient with acute infections requiring intravenous antibiotics.
- Frequent vomiting or medical condition that could interfere with oral medication
intake (eg, partial bowel obstruction).
- Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency
syndrome (AIDS)-related illness.
- Woman who is pregnant or breastfeeding.
- Patient with a history of hypersensitivity to temozolomide or other analogic
alkylating agents.
- Patient with any other conditions under which investigators think the subject is not
suitable for enrolment, such like having known that the subject may not have good
compliance.