GlioblastomaPhase 3CeTeGNCT01149109
Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
A Phase 3 study testing Temozolomide and lomustine and Temozolomide in people with Glioblastoma, run by University Hospital, Bonn at 12 sites in Germany.
Trial summary
The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide and lomustine and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 12 sitesGermany
- Study dates
- Oct 2010to 6 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- patients have to be in a cognitive state that allows them to understand the rationale and necessity of study therapy and procedures.
- newly diagnosed histologically proven GBM or gliosarcoma WHO Grad IV
- methylated MGMT promoter in the tumor
- estimated life expectancy of at least 12 weeks
- Karnofsky Performance Score (KPS) ≥ 70%
Show all 14Show fewer
- patient compliance and geographic proximity that allow adequate follow up
- male and female patients with reproductive potential must use an approved contraceptive method
- pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
- Adequate organ function as described below:
- Adequate bone marrow reserve:
- white blood cell (WBC) count > 3000/µl, granulocyte count >1500/µl, platelets > 100000/µl, haemoglobin ≥ 10 g/dl Adequate liver function bilirubin < 1.5 times above upper limit of normal range (ULN), ALT and AST < 3 times ULN creatinine < 1.5 times ULN
- Adequate blood clotting:
- PT and PTT within normal limits Negative HIV test
Who cannot join
- prior malignancy
- prior chemotherapy
- prior radiotherapy to the brain
- concurrent administration of any other anti-tumor therapy
- allergy or other intolerability of temozolomide, CCNU, dacarbazine or other nitrosourea derivatives
- unable to undergo MRI
Show all 13Show fewer
- past medical history of diseases with poor prognosis
- known HIV infection, active Hepatitis B or C infection
- any active infection
- female patients that are pregnant or breastfeeding
- patients with reproductive potential who do not accept to use contraception
- treatment in another clinical trial
- any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up scheduled visits (at the discretion of investigator)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Depatment of Neurosurgery, Charité, University Hospital Berlin
Berlin, 13353
Department of Neurology, University Hospital Bochum
Bochum, 44892
Department of Neurology, University Hospital Bonn
Bonn, 53105
Department of Neurosurgery, University Hospital Cologne
Cologne, 50937
Department of Neurosurgery, University Hospital Dresden
Dresden, 01307
Department of Neurosurgery, University Hospital Duesseldorf
Düsseldorf, 40225
Department of Neurosurgery, University Hospital Frankfurt
Frankfurt, 60528
Department of Radiooncology, University Hospital Leipzig
Leipzig, 04103
Department of Neurosurgery, University of Heidelberg, Medical Faculty of Mannheim
Mannheim, 68167
Department of Neurosurgery, University Hospital Munich (LMU)
Munich, 81377
Department of Neurosurgery, University Hospital Muenster
Münster, 48149
Department of Neurology, University Hospital Regensburg
Regensburg, 93053
About this study
Official title: Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients
The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide and lomustine, Temozolomide
- Keywords
- MGMT promotor status, overall survival
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide and lomustineDrug
Also called Temodal, Temomedac, CeCeNu
TemozolomideDrug
Also called Temodal, Temomedac
| Study group | Role | What they receive |
|---|---|---|
| lomustine (CCNU) + temozolomide (TMZ) and radiotherapy | Experimental | 60 Gy standard radiotherapy (RT, 30 x 2 Gy) Six 42-day courses of oral CCNU 100 mg/m2 (day 1) and oral TMZ 100 mg/m2 (day 2-6), first CCNU application during the first week of RT CCNU/TMZ and radiotherapy start 2-5 weeks after diagnosis (day of surgery for glioblastoma (GBM)). In courses 2-6, TMZ dose are adjusted according to the hematotoxicity observed in the previous course and can be increased stepwise up to 200 mg/m2/day Receives: Drug: Temozolomide and lomustine |
| temozolomide and radiotherapy | Active comparator | 60 Gy standard radiotherapy (RT, 30 x 2 Gy) and concomitant TMZ therapy (daily TMZ 75 mg/m2) starting with the first day of radiotherapy Six 28-day courses of TMZ (day 1-5) starting 4 weeks after completion of radiotherapy. In the first course TMZ is given at a dose of 150 mg/m2/day, in case no toxicity is observed, the 2nd course is applied at a daily dose of 200 mg/m2 Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: after follow up (4 years)
Secondary outcomes (6)
progression free survival
Measured: after follow up (4 years)
best response rate determined by MRI
Measured: after follow up (4 years)
frequency of delay of the next Lomustine/Temozolomide or Temozolomide course
Measured: during treatment period (2 years)
acute toxicity during radiotherapy and chemotherapy according to CTC AE V3.0
Measured: during treatment period (2 years)
quality of life
Measured: including follow up (4 years)
Evaluation of late neurotoxicity
Measured: after follow up (4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startOct 2010
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Herrlinger, University Hospital, Bonn
- Investigators
- Ulrich Herrlinger, Prof. Dr., Study director, Division of Neurooncology, Departement of Neurology, University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149109
- Sponsor's protocol ID
- CeTeG
- Other IDs
- 2009-011252-22, 2009
- Acronym
- CeTeG
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2010
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weller J, Schafer N, Schaub C, Tzaridis T, Zeyen T, Schneider M, Potthoff AL, Giordano FA, Steinbach JP, Zeiner PS, Kowalski T, Sabel M, Hau P, Krex D, Grauer O, Goldbrunner R, Schnell O, Tabatabai G, Ringel F, Schmidt-Graf F, Brehmer S, Tonn JC, Bullinger L, Vajkoczy P, Glas M, Vatter H, Herrlinger U, Seidel C. Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG/NOA-09 trial. J Neurooncol. 2023 Jan;161(1):147-153. doi: 10.1007/s11060-022-04203-4. Epub 2023 Jan 7.
PubMed 36609807Tzaridis T, Schafer N, Weller J, Steinbach JP, Schlegel U, Seidel S, Sabel M, Hau P, Seidel C, Krex D, Goldbrunner R, Tonn JC, Grauer O, Kebir S, Schneider M, Schaub C, Vatter H, Coch C, Glas M, Fimmers R, Pietsch T, Reifenberger G, Herrlinger U, Felsberg J. MGMT promoter methylation analysis for allocating combined CCNU/TMZ chemotherapy: Lessons learned from the CeTeG/NOA-09 trial. Int J Cancer. 2021 Apr 1;148(7):1695-1707. doi: 10.1002/ijc.33363. Epub 2020 Nov 10.
PubMed 33113214Weller J, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Hau P, Krex D, Grauer O, Goldbrunner R, Bahr O, Uhl M, Seidel C, Tabatabai G, Brehmer S, Bullinger L, Galldiks N, Schaub C, Kebir S, Stummer W, Simon M, Fimmers R, Coch C, Glas M, Herrlinger U, Schafer N. Health-related quality of life and neurocognitive functioning with lomustine-temozolomide versus temozolomide in patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1444-1453. doi: 10.1016/S1470-2045(19)30502-9. Epub 2019 Sep 2.
PubMed 31488360Herrlinger U, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Sabel M, Hau P, Kortmann RD, Krex D, Grauer O, Goldbrunner R, Schnell O, Bahr O, Uhl M, Seidel C, Tabatabai G, Kowalski T, Ringel F, Schmidt-Graf F, Suchorska B, Brehmer S, Weyerbrock A, Renovanz M, Bullinger L, Galldiks N, Vajkoczy P, Misch M, Vatter H, Stuplich M, Schafer N, Kebir S, Weller J, Schaub C, Stummer W, Tonn JC, Simon M, Keil VC, Nelles M, Urbach H, Coenen M, Wick W, Weller M, Fimmers R, Schmid M, Hattingen E, Pietsch T, Coch C, Glas M; Neurooncology Working Group of the German Cancer Society. Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial. Lancet. 2019 Feb 16;393(10172):678-688. doi: 10.1016/S0140-6736(18)31791-4. Epub 2019 Feb 14.
PubMed 30782343
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT01149109
- Acronym / sponsor ID
- CeTeG / CeTeG
- Conditions
- Glioblastoma
- Keywords
- MGMT promotor status, overall survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 23 Jun 2010 (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 prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lomustine (CCNU) + temozolomide (TMZ) and radiotherapy | Experimental | Drug: Temozolomide and lomustine60 Gy standard radiotherapy (RT, 30 x 2 Gy) Six 42-day courses of oral CCNU 100 mg/m2 (day 1) and oral TMZ 100 mg/m2 (day 2-6), first CCNU application during the first week of RT CCNU/TMZ and radiotherapy start 2-5 weeks after diagnosis (day of surgery for glioblastoma (GBM)). In courses 2-6, TMZ dose are adjusted according to the hematotoxicity observed in the previous course and can be increased stepwise up to 200 mg/m2/day |
| temozolomide and radiotherapy | Active comparator | Drug: Temozolomide60 Gy standard radiotherapy (RT, 30 x 2 Gy) and concomitant TMZ therapy (daily TMZ 75 mg/m2) starting with the first day of radiotherapy Six 28-day courses of TMZ (day 1-5) starting 4 weeks after completion of radiotherapy. In the first course TMZ is given at a dose of 150 mg/m2/day, in case no toxicity is observed, the 2nd course is applied at a daily dose of 200 mg/m2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- written informed consent
- patients have to be in a cognitive state that allows them to understand the rationale and necessity of study therapy and procedures.
- newly diagnosed histologically proven GBM or gliosarcoma WHO Grad IV
- methylated MGMT promoter in the tumor
- estimated life expectancy of at least 12 weeks
Key exclusion criteria (13 listed)
- prior malignancy
- prior chemotherapy
- prior radiotherapy to the brain
- concurrent administration of any other anti-tumor therapy
- allergy or other intolerability of temozolomide, CCNU, dacarbazine or other nitrosourea derivatives
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 and lomustineAlso: Temodal, Temomedac, CeCeNu | Drug | lomustine (CCNU) + temozolomide (TMZ) and radiotherapy |
| TemozolomideAlso: Temodal, Temomedac | Drug | temozolomide and radiotherapy |
Primary outcome
overall survival
Time frame: after follow up (4 years)
6 secondary outcomes
progression free survival
Time frame: after follow up (4 years)
best response rate determined by MRI
Time frame: after follow up (4 years)
frequency of delay of the next Lomustine/Temozolomide or Temozolomide course
Time frame: during treatment period (2 years)
acute toxicity during radiotherapy and chemotherapy according to CTC AE V3.0
Time frame: during treatment period (2 years)
quality of life
Time frame: including follow up (4 years)
Evaluation of late neurotoxicity
Time frame: after follow up (4 years)
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 14 Jun 2017.
- Derived from this study: PubMed 36609807Weller J, Schafer N, Schaub C, Tzaridis T, Zeyen T, Schneider M, Potthoff AL, Giordano FA, Steinbach JP, Zeiner PS, Kowalski T, Sabel M, Hau P, Krex D, Grauer O, Goldbrunner R, Schnell O, Tabatabai G, Ringel F, Schmidt-Graf F, Brehmer S, Tonn JC, Bullinger L, Vajkoczy P, Glas M, Vatter H, Herrlinger U, Seidel C. Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG/NOA-09 trial. J Neurooncol. 2023 Jan;161(1):147-153. doi: 10.1007/s11060-022-04203-4. Epub 2023 Jan 7.
- Derived from this study: PubMed 33113214Tzaridis T, Schafer N, Weller J, Steinbach JP, Schlegel U, Seidel S, Sabel M, Hau P, Seidel C, Krex D, Goldbrunner R, Tonn JC, Grauer O, Kebir S, Schneider M, Schaub C, Vatter H, Coch C, Glas M, Fimmers R, Pietsch T, Reifenberger G, Herrlinger U, Felsberg J. MGMT promoter methylation analysis for allocating combined CCNU/TMZ chemotherapy: Lessons learned from the CeTeG/NOA-09 trial. Int J Cancer. 2021 Apr 1;148(7):1695-1707. doi: 10.1002/ijc.33363. Epub 2020 Nov 10.
- Derived from this study: PubMed 31488360Weller J, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Hau P, Krex D, Grauer O, Goldbrunner R, Bahr O, Uhl M, Seidel C, Tabatabai G, Brehmer S, Bullinger L, Galldiks N, Schaub C, Kebir S, Stummer W, Simon M, Fimmers R, Coch C, Glas M, Herrlinger U, Schafer N. Health-related quality of life and neurocognitive functioning with lomustine-temozolomide versus temozolomide in patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1444-1453. doi: 10.1016/S1470-2045(19)30502-9. Epub 2019 Sep 2.
- Derived from this study: PubMed 30782343Herrlinger U, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Sabel M, Hau P, Kortmann RD, Krex D, Grauer O, Goldbrunner R, Schnell O, Bahr O, Uhl M, Seidel C, Tabatabai G, Kowalski T, Ringel F, Schmidt-Graf F, Suchorska B, Brehmer S, Weyerbrock A, Renovanz M, Bullinger L, Galldiks N, Vajkoczy P, Misch M, Vatter H, Stuplich M, Schafer N, Kebir S, Weller J, Schaub C, Stummer W, Tonn JC, Simon M, Keil VC, Nelles M, Urbach H, Coenen M, Wick W, Weller M, Fimmers R, Schmid M, Hattingen E, Pietsch T, Coch C, Glas M; Neurooncology Working Group of the German Cancer Society. Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial. Lancet. 2019 Feb 16;393(10172):678-688. doi: 10.1016/S0140-6736(18)31791-4. Epub 2019 Feb 14.
- Clinical Neuro-Oncology, University of BonnLink provided by the sponsor.
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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.
Ulrich Herrlinger, Prof. Dr. study director
Division of Neurooncology, Departement of Neurology, University Hospital Bonn
12 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 and lomustine and Temozolomide in people with Glioblastoma, run by University Hospital, Bonn at 12 sites in Germany.
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 14 inclusion and 13 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. 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 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?
overall survival (time frame: after follow up (4 years)). 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 NCT01149109, which also lists 4 linked publications.
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 14 Jun 2017.