Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)
Condition: Glioblastoma
MeSH terms: Glioblastoma
Intervention: Temozolomide; Radiotherapy
Intervention MeSH terms: Temozolomide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery
      temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the
      standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma
      multiforme.
    

Eligibility criteria:

        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.