GlioblastomaPhase 2PATSGONCT00643825
Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients
A Phase 2 study testing Temozolomide in people with Glioblastoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2008to Jan 2012
- Phase
- Phase 2
- 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
- Patients with histologically confirmed diagnosis of GBM
- Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended
- Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy.
- A brain MRI with or without a PET-Scan-methionine must be performed before enrolment.
- Age ≥ 18 years
- Karnofsky Performance status ≥ 60
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- Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l
- Normal liver function: total bilirubin < 1.5 x ULN, alkaline phosphatase and transaminases (ASAT/ALAT) < 2.5 times the upper limit of the normal range
- Serum creatinine < 1.5 x ULN
- Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia
- No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast).
- All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study.
- Signed informed consent from the patient or legal representative must be obtained.
Who cannot join
- All non inclusion criteria
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Europe, 1200
Jean-Francois BAURAIN, MD, PhD, +32 2 764 54 71, jean-francois.baurain@@uclouvain.be
About this study
Official title: Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or "Stop and Go" in Glioblastoma Patients: The PATSGO Study
This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).
- Conditions
- Glioblastoma
- Being tested
- Temozolomide
- Keywords
- Temozolomide, Phase II, Chemotherapy, Glioblastoma, Progression-free Survival
- 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 TEMODAR, TEMODAL
Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
TemozolomideDrug
Also called TEMODAR, TEMODAL
Observation till Progression then rechallenging with TMZ
| Study group | Role | What they receive |
|---|---|---|
| A: prolonged adj TMZ | Active comparator | Not described Receives: Drug: Temozolomide |
| B : Stop and Go | Other | Rechallenging patients with TMZ at relapse Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months
Measured: 36 months
Secondary outcomes (1)
safety and adverse event profile of prolonged adjuvant Temozolomide
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Francois Baurain, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643825
- Sponsor's protocol ID
- UCL-ONCO 06-004
- Acronym
- PATSGO
- Status last verified
- Jul 2010
- First submitted
- 20 Mar 2008
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or "Stop and Go" in Glioblastoma Patients: The PATSGO Study
- ClinicalTrials.gov ID
- NCT00643825
- Acronym / sponsor ID
- PATSGO / UCL-ONCO 06-004
- Conditions
- Glioblastoma
- Keywords
- Temozolomide, Phase II, Chemotherapy, Glioblastoma, Progression-free Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 26 Mar 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.
This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: prolonged adj TMZ | Active comparator | Drug: Temozolomide |
| B : Stop and Go | Other | Drug: TemozolomideRechallenging patients with TMZ at relapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with histologically confirmed diagnosis of GBM
- Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended
- Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy.
- A brain MRI with or without a PET-Scan-methionine must be performed before enrolment.
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- All non inclusion criteria
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, TEMODALCapsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD | Drug | A: prolonged adj TMZ |
| TemozolomideAlso: TEMODAR, TEMODALObservation till Progression then rechallenging with TMZ | Drug | B : Stop and Go |
Primary outcome
to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months
Time frame: 36 months
1 secondary outcome
safety and adverse event profile of prolonged adjuvant Temozolomide
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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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.
Jean-Francois Baurain, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Glioblastoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 13 inclusion and 1 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 23 Jul 2010. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jean-Francois BAURAIN, MD, PhD (+32 2 764 54 71, jean-francois.baurain@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months (time frame: 36 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 23 Jul 2010.