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Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00704808
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : April 2, 2010
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date June 23, 2008
First Posted Date June 25, 2008
Results First Submitted Date March 17, 2010
Results First Posted Date April 2, 2010
Last Update Posted Date September 9, 2015
Study Start Date May 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2010)
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme [ Time Frame: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide ]
Original Primary Outcome Measures
 (submitted: June 23, 2008)
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ]
Change History Complete list of historical versions of study NCT00704808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 23, 2008)
  • Assessment of toxicity (per National Cancer Institute Common Toxicity Criteria) [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ]
  • Progression free survival [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ]
  • Determination of overall survival [ Time Frame: One year from end of treatment. ]
  • Karnofsky performance status [ Time Frame: One year from end of treatment. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Official Title Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
Brief Summary The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with newly diagnosed glioblastoma multiforme.
Condition Glioblastoma
Intervention
  • Procedure: Primary surgical treatment
    Primary surgery for tumor resection.
    Other Names:
    • Resection
    • Operation
    • Surgery
  • Radiation: Radiotherapy
    Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
    Other Names:
    • Irradiation
    • Radiation therapy
  • Drug: Temozolomide
    Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.
    Other Names:
    • Temodal
    • Temodar
    • SCH 052365
Study Groups/Cohorts Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
Interventions:
  • Procedure: Primary surgical treatment
  • Radiation: Radiotherapy
  • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2008)
180
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).
  • Age >=18 years.
  • Hemoglobin >=10 g/dL.
  • White blood cell count >=1.5x10^9/L.
  • Platelet count >=100x10^9/L.
  • Blood urea <=1.5 x upper limit of normal values (ULN).
  • Creatinine <=1.5 x ULN.
  • Bilirubin <=1.5 x ULN.
  • Aspartate aminotransferase <=3 x ULN.
  • Alanine aminotransferase <=3 x ULN.
  • Alkaline phosphatase <=2 x ULN.

Exclusion Criteria:

  • Tumor-specific pretreatment.
  • Contraindication against radiotherapy and/or chemotherapy.
  • Malignomas other than basaliomas.
  • Existing or planned pregnancy or lactation or inadequate contraception.
  • Psychiatric disease.
  • Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00704808
Other Study ID Numbers P04739
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2015