Clinical trial NCT00686725: Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glioblastoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Objective Tumor Assessment After Surgery: Overall Response
timeFrame: Up to 2 years
measure: Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group
timeFrame: Up to 2 years
measure: Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group
timeFrame: Up to 2 years
measure: Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group
timeFrame: 6, 12, & 18 months
measure: Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group
timeFrame: 6, 12, & 18 months
measure: Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group
timeFrame: Up to 2 years
measure: Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Mao Y, Yao Y, Zhang LW, Lu YC, Chen ZP, Zhang JM, Qi ST, You C, Wang RZ, Yang SY, Zhang X, Wang JS, Chen JX, Yang QY, Shen H, Li ZY, Wang X, Ma WB, Yang XJ, Zhen HN, Zhou LF. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial. Chin Med J (Engl). 2015 Oct 20;128(20):2751-8. doi: 10.4103/0366-6999.167313.