Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

An observational study of Glioblastoma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting. Read more about this study

Who is it for?: Any age
Conditions the study is for: Glioblastoma
What is being tested?: Temozolomide and Radiotherapy
Type of treatment: Pill or oral medicine, Surgery or procedure
How many people: 64 participants
Where: No sites listed yet
Study dates: Apr 2007to Apr 2009
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Subjects with newly diagnosed Glioblastoma multiforme

Who may be able to join

Newly diagnosed Glioblastoma multiforme

Who cannot join

History of hypersensitivity to temozolomide or its components, or to dacarbazine.
Women who are pregnant or breast-feeding.
Patients with severe myelosuppression.

About this study

Official title: Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program

Read the detailed description

Participant sampling method: consecutive patient sampling.

Conditions: Glioblastoma
Being tested: Temozolomide, Radiotherapy
Medical subject headings: Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TemozolomideDrug
Also called Temodal, Temodar, SCH 052365
Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.
RadiotherapyRadiation
Also called Radiation therapy, Irradiation
Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.

Study groups in NCT00725010
Study group	Role	What they receive
Patients		Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care. Receives: Drug: Temozolomide; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Number of Adverse Events in the Indicated Categories
Measured: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Number of Participants Who Discontinued Due to Toxicity
Measured: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Apr 2009

First posted30 Jul 2008 (estimated)
Study startApr 2007
Primary completionApr 2009
Study completionApr 2009

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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00725010
Sponsor's protocol ID: P04816
Status last verified: Sep 2015
First submitted: 25 Jul 2008
Last updated: 9 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

All Glioblastoma trials

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: Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program
ClinicalTrials.gov ID: NCT00725010
Acronym / sponsor ID: P04816
Conditions: Glioblastoma
Study type: Observational
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participant sampling method: consecutive patient sampling.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients	–	Drug: Temozolomide, Radiation: RadiotherapyParticipants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects with newly diagnosed Glioblastoma multiforme

Key inclusion criteria (1 listed)

Newly diagnosed Glioblastoma multiforme

Key exclusion criteria (3 listed)

History of hypersensitivity to temozolomide or its components, or to dacarbazine.
Women who are pregnant or breast-feeding.
Patients with severe myelosuppression.

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
TemozolomideAlso: Temodal, Temodar, SCH 052365Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.	Drug	Patients
RadiotherapyAlso: Radiation therapy, IrradiationRadiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.	Radiation	Patients

Primary outcome

Safety: Number of Adverse Events in the Indicated Categories
Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Number of Participants Who Discontinued Due to Toxicity
Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Planned Temozolomide+Radiotherapy	50	25

Primary outcome: Safety: Number of Adverse Events in the Indicated Categories

Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase. Number. Unit: Adverse Events

Measure	Temozolomide+Radiotherapy n = 44	Temozolomide Alone n = 6
Unlikely Related to Temozolomide	35	1
Possibly Related to Temozolomide	14	0
Probably Related to Temozolomide	22	1

Primary outcome: Number of Participants Who Discontinued Due to Toxicity

Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase. Number. Unit: Participants

Measure	Temozolomide+Radiotherapy n = 44	Temozolomide Alone n = 6
Value	8	1

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Temozolomide+Radiotherapy	8 of 44 (18.2%)	12 of 44 (27.3%)	Not reported
Temozolomide Alone	1 of 6 (16.7%)	1 of 6 (16.7%)	Not reported

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.

Related trials for Glioblastoma

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

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 1 inclusion and 3 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 18 Nov 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?

Safety: Number of Adverse Events in the Indicated Categories (time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00725010.

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.