Glioblastoma Multiforme of BrainPhase 3NCT03633552
Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
A Phase 3 study testing Temozolomide in people with Glioblastoma Multiforme of Brain and Anaplastic Astrocytoma of Brain, run by Mashhad University of Medical Sciences at 2 sites in Iran.
Trial summary
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme of Brain, Anaplastic Astrocytoma of Brain
- What is being tested?
- Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesIran
- Study dates
- 3 Mar 2018to 3 Apr 2021
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed glioblastoma and anaplastic astrocytoma
- age between 18 and 70 years
- Karnofsky Performance Scale Index equal or more than 60 percent
- signed informed consent
Who cannot join
- chronic hepatic
- renal failure
- cardiac failure
- history of hematologic malignancies
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Radiation ward of Emam Reza Hospital
Mashhad, Razavi Khorasan Province, 9137913316
Roham Salek, M.D., +985138426936, SalekR@mums.ac.ir
Kazem Anvari, M.D.
- Recruiting
Omid Hospital
Mashhad, Razavi Khorasan Province, 917661377
Seyed Amir Aledavood, M.D., +985138426936, AledavoodA@mums.ac.ir
Kazem Anvari, M.D.
About this study
Official title: A Single-blind, Randomized, Clinical Trial Comparing the Efficacy of 6 Cycles Versus 12 Cycles Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Read the detailed description
This study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure. The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study. The primary endpoints of study are overall survival and progression free survival.
- Being tested
- Temozolomide
- Keywords
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Adjuvant treatment, Extended chemotherapy
- Medical subject headings
- Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar, Temodal, Temcad, Glidar
The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage).
| Study group | Role | What they receive |
|---|---|---|
| 12-cycle arm | Experimental | After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). Receives: Drug: Temozolomide |
| 6-cycle arm | Active comparator | After completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time interval between the diagnosis and death.
Measured: up to 1 year from start of treatment
Progression-free survival
The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms
Measured: up to 1 year from start of treatment
Secondary outcomes (5)
Anemia
blood hemoglobin lower than 10 grams per deciliter
Measured: monthly, up to 12 months during treatment
Neutropenia
Blood almost mature neutrophils count lower than 1500/mm3
Measured: monthly, up to 12 months during treatment
Presence of alopecia
A condition in which hair is lost
Measured: monthly, up to 12 months during treatment
Presence of nausea
An unpleasant sense of unease, discomfort, and revulsion towards food
Measured: monthly, up to 12 months during treatment
Presence of vomiting
Eject matter from the stomach through the mouth.
Measured: monthly, up to 12 months during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start3 Mar 2018
- Primary completion3 Mar 2021 (estimated)
- Study completion3 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyed Alireza Javadinia, Mashhad University of Medical Sciences
- Investigators
- Mahdi Silanian Toosi, M.D., Study director, Mashhad University of Medical SciencesKazem Anvari, M.D., Study chair, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633552
- Sponsor's protocol ID
- 960021
- Other IDs
- IRCT20160706028815N3
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make this available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Clinical Trial Comparing the Efficacy of 6 Cycles Versus 12 Cycles Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
- ClinicalTrials.gov ID
- NCT03633552
- Acronym / sponsor ID
- 960021
- Keywords
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Adjuvant treatment, Extended chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 3 Mar 2021 (estimated)
- Study completion
- 3 Apr 2021 (estimated)
- First posted
- 16 Aug 2018 (actual)
- 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.
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Detailed description
This study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure. The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study. The primary endpoints of study are overall survival and progression free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
| Arm | Type | Receives |
|---|---|---|
| 12-cycle arm | Experimental | Drug: TemozolomideAfter completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). |
| 6-cycle arm | Active comparator | Drug: TemozolomideAfter completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed glioblastoma and anaplastic astrocytoma
- age between 18 and 70 years
- Karnofsky Performance Scale Index equal or more than 60 percent
- signed informed consent
Key exclusion criteria (4 listed)
- chronic hepatic
- renal failure
- cardiac failure
- history of hematologic malignancies
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: Temodar, Temodal, Temcad, GlidarThe patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). | Drug | 12-cycle arm, 6-cycle arm |
Primary outcome
Overall survival
Time frame: up to 1 year from start of treatment
The time interval between the diagnosis and death.
Progression-free survival
Time frame: up to 1 year from start of treatment
The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms
5 secondary outcomes
Anemia
Time frame: monthly, up to 12 months during treatment
Neutropenia
Time frame: monthly, up to 12 months during treatment
Presence of alopecia
Time frame: monthly, up to 12 months during treatment
Presence of nausea
Time frame: monthly, up to 12 months during treatment
Presence of vomiting
Time frame: monthly, up to 12 months during treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make this available.
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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.
Mahdi Silanian Toosi, M.D. study director
Mashhad University of Medical Sciences
Kazem Anvari, M.D. study chair
Mashhad University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temozolomide in people with Glioblastoma Multiforme of Brain and Anaplastic Astrocytoma of Brain, run by Mashhad University of Medical Sciences at 2 sites in Iran.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyed Alireza Javadinia, M.D. (00989155728157, Javadiniaa941@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 1 year from start of treatment). 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?
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 16 Aug 2018.