GlioblastomaNCT00704808
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
An observational study of Glioblastoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Primary surgical treatment, Radiotherapy and Temozolomide
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Dec 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed glioblastoma multiforme.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
About this study
Official title: Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
- Conditions
- Glioblastoma
- Being tested
- Primary surgical treatment, Radiotherapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary surgical treatmentProcedure or surgery
Also called Resection, Operation, Surgery
Primary surgery for tumor resection.
RadiotherapyRadiation
Also called Irradiation, Radiation therapy
Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
TemozolomideDrug
Also called Temodal, Temodar, SCH 052365
Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with newly diagnosed and operated glioblastoma multiforme. Receives: Procedure: Primary surgical treatment; Radiation: Radiotherapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
Measured: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704808
- Sponsor's protocol ID
- P04739
- Status last verified
- Sep 2015
- First submitted
- 23 Jun 2008
- Last updated
- 9 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00704808
- Acronym / sponsor ID
- P04739
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Posted 2 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Primary surgical treatment, Radiation: Radiotherapy, Drug: TemozolomidePatients with newly diagnosed and operated glioblastoma multiforme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed glioblastoma multiforme.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- Tumor-specific pretreatment.
- Contraindication against radiotherapy and/or chemotherapy.
- Malignomas other than basaliomas.
- Existing or planned pregnancy or lactation or inadequate contraception.
- Psychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary surgical treatmentAlso: Resection, Operation, SurgeryPrimary surgery for tumor resection. | Procedure or surgery | Patients |
| RadiotherapyAlso: Irradiation, Radiation therapyRadiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics. | Radiation | Patients |
| TemozolomideAlso: Temodal, Temodar, SCH 052365Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics. | Drug | Patients |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.