Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)

This is an interventional treatment trial for Glioblastoma Read More

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.