GliomaNCT00705198
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
An observational study of Glioma and Astrocytoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma, Astrocytoma
- What is being tested?
- Temozolomide (for newly diagnosed malignant glioma), Temozolomide (for relapsed malignant glioma) and Radiotherapy (for patients with newly diagnosed malignant glioma)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,804 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy). In addition, up to 450 patients with newly diagnosed anaplastic astrocytoma will be registered to investigate survival time.
Who may be able to join
- All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).
Who cannot join
- Patients with a history of hypersensitivity to temozolomide or dacarbazine.
- Pregnant women and women who may be pregnant.
About this study
Official title: Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)
The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Read the detailed description
Patients are invited to participate in the study.
- Conditions
- Glioma, Astrocytoma
- Being tested
- Temozolomide (for newly diagnosed malignant glioma), Temozolomide (for relapsed malignant glioma), Radiotherapy (for patients with newly diagnosed malignant glioma)
- Medical subject headings
- Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide (for newly diagnosed malignant glioma)Drug
Also called Temodal, Temodar, SCH 052365
Temozolomide treatment for newly diagnosed malignant glioma. The usual dose for adults in combination with radiotherapy is 75 mg/m2 orally once daily for 42 consecutive days. After a 4 week rest period, monotherapy at 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle is administered. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.
Temozolomide is administered as 20 mg and 100 mg capsules.
Temozolomide (for relapsed malignant glioma)Drug
Also called Temodal, Temodar, SCH 052365
Temozolomide treatment for relapsed malignant glioma. The usual dose for adults is 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.
Temozolomide is administered as 20 mg and 100 mg capsules.
Radiotherapy (for patients with newly diagnosed malignant glioma)Radiation
Also called Radiation therapy
Although the study protocol does not clearly define how long this intervention is applied, radiotherapy is generally administered 5 days/week for 6 weeks to patients with newly diagnosed malignant glioma.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed patients | Patients treated with temozolomide for newly diagnosed malignant glioma Receives: Drug: Temozolomide (for newly diagnosed malignant glioma); Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma) | |
| Relapsed patients | Patients treated with temozolomide for relapsed malignant glioma Receives: Drug: Temozolomide (for relapsed malignant glioma) | |
| Newly diagnosed anaplastic astrocytoma patients | Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma Receives: Drug: Temozolomide (for newly diagnosed malignant glioma); Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.
Measured: AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.
Efficacy in patients registered during Period 1, evaluated as Remarkably Effective, Moderately Effective, Stable Disease, Progression, or Not Evaluable, considering tumor responses, progression free survival, overall survival, among other factors.
Measured: One year after start of temozolomide treatment.
Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival.
Measured: From the start of treatment with temozolomide to final outcome.
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 startSep 2006
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- 1,804 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
- NCT00705198
- Sponsor's protocol ID
- P05062
- Status last verified
- Nov 2016
- First submitted
- 23 Jun 2008
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)
- ClinicalTrials.gov ID
- NCT00705198
- Acronym / sponsor ID
- P05062
- Conditions
- Glioma, Astrocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,804 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
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 study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Detailed description
Patients are invited to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed patients | – | Drug: Temozolomide (for newly diagnosed malignant glioma), Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)Patients treated with temozolomide for newly diagnosed malignant glioma |
| Relapsed patients | – | Drug: Temozolomide (for relapsed malignant glioma)Patients treated with temozolomide for relapsed malignant glioma |
| Newly diagnosed anaplastic astrocytoma patients | – | Drug: Temozolomide (for newly diagnosed malignant glioma), Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy). In addition, up to 450 patients with newly diagnosed anaplastic astrocytoma will be registered to investigate survival time.
Key inclusion criteria (1 listed)
- All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to temozolomide or dacarbazine.
- Pregnant women and women who may be pregnant.
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 |
|---|---|---|
| Temozolomide (for newly diagnosed malignant glioma)Also: Temodal, Temodar, SCH 052365Temozolomide treatment for newly diagnosed malignant glioma. The usual dose for adults in combination with radiotherapy is 75 mg/m2 orally once daily for 42 consecutive days. After a 4 week rest period, monotherapy at 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle is administered. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle. Temozolomide is administered as 20 mg and 100 mg capsules. | Drug | Newly diagnosed anaplastic astrocytoma patients, Newly diagnosed patients |
| Temozolomide (for relapsed malignant glioma)Also: Temodal, Temodar, SCH 052365Temozolomide treatment for relapsed malignant glioma. The usual dose for adults is 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle. Temozolomide is administered as 20 mg and 100 mg capsules. | Drug | Relapsed patients |
| Radiotherapy (for patients with newly diagnosed malignant glioma)Also: Radiation therapyAlthough the study protocol does not clearly define how long this intervention is applied, radiotherapy is generally administered 5 days/week for 6 weeks to patients with newly diagnosed malignant glioma. | Radiation | Newly diagnosed anaplastic astrocytoma patients, Newly diagnosed patients |
Primary outcome
Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.
Time frame: AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.
Efficacy in patients registered during Period 1, evaluated as Remarkably Effective, Moderately Effective, Stable Disease, Progression, or Not Evaluable, considering tumor responses, progression free survival, overall survival, among other factors.
Time frame: One year after start of temozolomide treatment.
Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival.
Time frame: From the start of treatment with temozolomide to final outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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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 Glioma and Astrocytoma, 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 2 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 15 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide. (time frame: AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.). The study lists 3 primary outcomes in all. 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 15 Nov 2016.