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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.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Glioblastoma
Interventions Procedure: Primary surgical treatment
Radiation: Radiotherapy
Drug: Temozolomide
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temozolomide
Hide Arm/Group Description Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
Period Title: Overall Study
Started 180
Completed 49
Not Completed 131
Reason Not Completed
Discontinued prior to starting treatment             14
Death             7
Tumor progression             80
Patient's decision             11
Early therapy discontinuation             16
Adverse Event             1
Lost to Follow-up             1
Treatment change             1
Arm/Group Title Temozolomide
Hide Arm/Group Description Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
Overall Number of Baseline Participants 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants
57.65  (11.52)
[1]
Measure Description: Mean age data based on 165 participants (one less than the Intent-to-treat (ITT) population of 166) due to missing data for 1 participant.
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 180 participants
Female 65
Male 101
Unavailable 14
[1]
Measure Description: Gender information only available for the Intent-to-Treat population of 166 participants.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 180 participants
180
1.Primary Outcome
Title Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
Hide Description [Not Specified]
Time Frame After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population
Arm/Group Title Temozolomide
Hide Arm/Group Description:
Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
Overall Number of Participants Analyzed 166
Median (Standard Error)
Unit of Measure: Months
9.57  (1.18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temozolomide
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Temozolomide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Temozolomide
Affected / at Risk (%) # Events
Total   49/166 (29.52%)    
Blood and lymphatic system disorders   
PANCYTOPENIA  1  3/166 (1.81%)  3
THROMBOCYTOPENIA  1  2/166 (1.20%)  2
Cardiac disorders   
CARDIAC FAILURE  1  1/166 (0.60%)  1
Eye disorders   
VISUAL IMPAIRMENT  1  1/166 (0.60%)  1
Gastrointestinal disorders   
NAUSEA  1  2/166 (1.20%)  2
PERITONITIS  1  1/166 (0.60%)  1
VOMITING  1  2/166 (1.20%)  2
General disorders   
DEATH  1  7/166 (4.22%)  7
GENERAL PHYSICAL HEALTH DETERIORATION  1  7/166 (4.22%)  8
IMPAIRED HEALING  1  3/166 (1.81%)  4
Infections and infestations   
HERPES ZOSTER  1  1/166 (0.60%)  1
Injury, poisoning and procedural complications   
FEMUR FRACTURE  1  1/166 (0.60%)  1
Investigations   
LIVER FUNCTION TEST ABNORMAL  1  1/166 (0.60%)  1
TRANSAMINASES INCREASED  1  1/166 (0.60%)  1
Metabolism and nutrition disorders   
DIABETES MELLITUS  1  1/166 (0.60%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MALIGNANT NEOPLASM PROGRESSION  1  3/166 (1.81%)  3
Nervous system disorders   
BRAIN OEDEMA  1  1/166 (0.60%)  1
CONVULSION  1  4/166 (2.41%)  4
GRAND MAL CONVULSION  1  1/166 (0.60%)  1
HYDROCEPHALUS  1  2/166 (1.20%)  2
PARAESTHESIA  1  1/166 (0.60%)  1
PARTIAL SEIZURES  1  5/166 (3.01%)  5
Respiratory, thoracic and mediastinal disorders   
ACUTE RESPIRATORY FAILURE  1  2/166 (1.20%)  2
PULMONARY EMBOLISM  1  5/166 (3.01%)  5
Skin and subcutaneous tissue disorders   
ERYTHEMA  1  1/166 (0.60%)  1
Social circumstances   
SOCIAL STAY HOSPITALISATION  1  1/166 (0.60%)  1
Surgical and medical procedures   
APPENDICECTOMY  1  1/166 (0.60%)  1
CEREBROSPINAL FLUID DRAINAGE  1  1/166 (0.60%)  1
CEREBROSPINAL FLUID RESERVOIR PLACEMENT  1  1/166 (0.60%)  1
HOSPITALISATION  1  8/166 (4.82%)  9
Vascular disorders   
DEEP VEIN THROMBOSIS  1  2/166 (1.20%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temozolomide
Affected / at Risk (%) # Events
Total   41/166 (24.70%)    
Gastrointestinal disorders   
CONSTIPATION  1  9/166 (5.42%)  13
NAUSEA  1  13/166 (7.83%)  13
General disorders   
FATIGUE  1  21/166 (12.65%)  22
Metabolism and nutrition disorders   
DECREASED APPETITE  1  9/166 (5.42%)  10
Nervous system disorders   
HEADACHE  1  12/166 (7.23%)  17
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publishing or dissemination of study results requires a written approval of the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704808    
Other Study ID Numbers: P04739
First Submitted: June 23, 2008
First Posted: June 25, 2008
Results First Submitted: March 17, 2010
Results First Posted: April 2, 2010
Last Update Posted: September 9, 2015