Recurrent GlioblastomaPhase 3NCT01830101
A Phase III Study of Re-Irradiation in Recurrent Glioblastoma
A Phase 3 study testing TMZ plus concurrent re-irradiation and Temozolomide in people with Recurrent Glioblastoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- TMZ plus concurrent re-irradiation and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
- radiographic evidence of tumour progression or recurrence
- 18 years or older
- ECOG 0 - 2
- signed informed consent form
Who cannot join
- tumour progression or recurrence within 3 months of initial concurrent chemoradiation
- 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
- more than one prior course of salvage chemo for recurrent disease
- prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
- prior head or neck RT except for T1 glottic cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.
Read the detailed description
This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.
- Conditions
- Recurrent Glioblastoma
- Being tested
- TMZ plus concurrent re-irradiation, Temozolomide
- Keywords
- recurrent glioblastoma, re-irradiation, continuous low-dose temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMZ plus concurrent re-irradiationDrug
Also called Temedol
TemozolomideDrug
Also called Temedol
low-dose temozolomide daily for one year
| Study group | Role | What they receive |
|---|---|---|
| TMZ plus concurrent re-irradiation | Experimental | TMZ plus concurrent re-irradiation Receives: Drug: TMZ plus concurrent re-irradiation; Drug: Temozolomide |
| TMZ alone | Experimental | TMZ alone Receives: Drug: TMZ plus concurrent re-irradiation; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
Measured: 2 months
Secondary outcomes (1)
To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2015 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: This study will not be proceeding due to lack of funding from anticipated sources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Patel, MD, Principal investigator, Cross Cancer InstituteGerald Lim, MD, Principal investigator, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830101
- Sponsor's protocol ID
- CCI-Patel-01
- Status last verified
- Feb 2014
- First submitted
- 13 Mar 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT01830101
- Acronym / sponsor ID
- CCI-Patel-01
- Conditions
- Recurrent Glioblastoma
- Keywords
- recurrent glioblastoma, re-irradiation, continuous low-dose temozolomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study will not be proceeding due to lack of funding from anticipated sources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 12 Apr 2013 (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 investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.
Detailed description
This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMZ plus concurrent re-irradiation | Experimental | Drug: TMZ plus concurrent re-irradiation, Drug: TemozolomideTMZ plus concurrent re-irradiation |
| TMZ alone | Experimental | Drug: TMZ plus concurrent re-irradiation, Drug: TemozolomideTMZ alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
- radiographic evidence of tumour progression or recurrence
- 18 years or older
- ECOG 0 - 2
- signed informed consent form
Key exclusion criteria (5 listed)
- tumour progression or recurrence within 3 months of initial concurrent chemoradiation
- 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
- more than one prior course of salvage chemo for recurrent disease
- prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
- prior head or neck RT except for T1 glottic cancer
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 |
|---|---|---|
| TMZ plus concurrent re-irradiationAlso: Temedol | Drug | TMZ alone, TMZ plus concurrent re-irradiation |
| TemozolomideAlso: Temedollow-dose temozolomide daily for one year | Drug | TMZ alone, TMZ plus concurrent re-irradiation |
Primary outcome
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
Time frame: 2 months
1 secondary outcome
To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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.
Samir Patel, MD principal investigator
Cross Cancer Institute
Gerald Lim, MD principal investigator
Tom Baker Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TMZ plus concurrent re-irradiation and Temozolomide in people with Recurrent Glioblastoma, run by AHS Cancer Control Alberta at 1 site in Canada.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma. (time frame: 2 months). 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 Mar 2016.