GlioblastomaPhase 2NCT02394665
Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma
A Phase 2 study testing Intensity Modulated Radiation Therapy, Temozolomide and Functional Assessment of Cancer Therapy-Brain (FACT-Br) in people with Glioblastoma, run by University of Miami at 1 site in United States.
Trial summary
In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although clinical gains have been achieved in the past, these have been modest, with a majority of patients succumbing to local disease progression within 2 years. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Intensity Modulated Radiation Therapy, Temozolomide and Functional Assessment of Cancer Therapy-Brain (FACT-Br)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of glioblastoma (WHO grade IV). Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.
- The tumor must have a supratentorial component
- Patients must have recovered from the effects of surgery, postoperative infection and other complications
- Karnofsky performance status > 70
- Age > 18 years
- Adequate bone marrow function defined as follows:
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- Absolute neutrophil count (ANC) >/= 1500 cells/mm^3
- Platelet count > 100,000 cells/mm^3
- Hemoglobin > 10.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb > 10.0 g/dL is acceptable.)
- Patients on full-dose anticoagulants (e.g., warfarin or low-molecular weight (LMW) heparin) must meet both of the following criteria:
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- Adequate renal function, defined as follows:
- Blood urea nitrogen (BUN) < 30 mg/dL
- Serum creatinine < 1.5 x upper limit of normal (ULN)
- Adequate hepatic function, as defined below:
- Bilirubin < 1.5 normal range
- Alanine transaminase (ALT) < 3x normal range
- Aspartate transaminase (AST) < 3x normal range
- Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy test must be done within 7 days prior to registration. Effective contraception (men and women) must be used in patients of child-bearing potential while on study treatment and for 6 months after.
- Ability to understand and the willingness to sign a written informed consent document
- Ability to have MRI Scans
- Ability to swallow capsules
Who cannot join
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity or cervix are all permissible)
- Recurrent malignant glioma or evidence of leptomeningeal spread
- Metastases detected below the tentorium or beyond the cranial vault
- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation therapy fields
- Prior radiation therapy or chemotherapy for glioblastoma
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- Severe, active co-morbidity, defined as follows:
- Symptomatic congestive heart failure of New York heart Association Class III or IV
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the last 6 months, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
- Severely impaired lung function as defined as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
- Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics
- Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition or known HIV seropositivity. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with HIV/AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
- Other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
- Pregnancy
- Women who are breast feeding
- Prior allergic reaction to temozolomide
- Treatment on any other therapeutic clinical protocol
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter their absorption of temozolomide (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Contraindications to MRI including but not limited to, pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steelworker or other implants
- Need to continue treatment with any prohibited medication (e.g. antioxidants) or have not completed the appropriate washout period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Dose Escalated, Targeted Radiation Therapy Using 3D Magnetic Resonance Spectroscopy Imaging (MRSI) in Newly Diagnosed Glioblastoma
In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although clinical gains have been achieved in the past, these have been modest, with a majority of patients succumbing to local disease progression within 2 years. New strategies for treatment need to be identified which enhance local control above the current treatment regimen in order to achieve further clinical gains in this disease. Favorable early experience with magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic imaging can identify active tumor beyond standard MRI as well as high risk regions at risk for local failure. There is also clinical evidence that limited field dose escalation with either simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible and safe. Coupling these findings provide the rationale for this proposed Phase II trial designed to define efficacy and toxicity of the novel treatment approach of whole brain volumetric 3D MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM patients.
Read the detailed description
This phase II study will investigate efficacy and safety of volumetric 3D MRSI-directed treatment for newly diagnosed GBM patients. This study will enroll 48 patients in order to obtain at least 40 patients receiving RT and temozolomide. Depending on the size and number of HTVs, a patient will receive either simultaneous integrated boost (SIB) with IMRT (Group 1) or SRS boost followed by IMRT 1 week later (Group 2). Duration of enrollment will be 2 years and minimum follow-up will be 2 years.
The duration of treatment and follow-up will occur as follows:
- Six weeks of RT with concurrent Temozolomide treatment;
- 3D MRSI at week 3 and at the end of RT;
- 28 day break;
- Adjuvant treatment with Temozolomide administered daily on days 1-5 of each cycle, for up to 12 cycles (one cycle = 28 days) which will include standard gadolinium enhanced MRI and 3D MRSI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant Temozolomide;
- Active follow-up at least every three months for one year after the end of adjuvant Temozolomide treatment;
- After one year follow-up for survival will occur every three months for one year.
- Conditions
- Glioblastoma
- Being tested
- Intensity Modulated Radiation Therapy, Temozolomide, Functional Assessment of Cancer Therapy-Brain (FACT-Br), Stereotactic Radiosurgery Boost, Simultaneous Integrated Boost
- Keywords
- Glioblastoma, Gliosarcoma, GBM
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Radiation TherapyRadiation
Also called IMRT, Fractionated RT
IMRT treatment will consist of 60 Gy in 30 fractions to PTV 60
TemozolomideDrug
Also called Temodar, Temodal
Concurrently during radiation therapy. Adjuvant therapy administered daily on days 1 - 5 for 12 cycles. One cycle = 28 days:
- Concurrent during Radiation Therapy: 75 mg/m^2 orally for 6 weeks;
- Post-radiation, adjuvant therapy: 150 mg/m^2 - 200 mg/m^2 orally daily on days 1 - 5 of each cycle.
Functional Assessment of Cancer Therapy-Brain (FACT-Br)Behavioural
Also called FACT-Br
FACT-Br Quality of Life (QOL) questionnaire to be completed by study patients as protocol specific timepoints
Stereotactic Radiosurgery BoostRadiation
Also called SRS Boost
Patients will undergo SRS boost in a single fraction dose prior to IMRT treatment:
HTV Maximum dimension vs. Prescribed Dose to HTV: ≤ 20 mm = 21 Gy; 21 mm - 30 mm = 18 Gy; 31 mm - 40 mm = 15 Gy.
Simultaneous Integrated BoostRadiation
Also called SIB
Treatment shall consist of 60 Gy in 30 fractions to planning target volume (PTV) 60 and 75 Gy in 30 fractions to PTV 75.
3D MRSIDevice
Also called 3D Magnetic Resonance Spectroscopy Imaging
Three Dimensional Magnetic Resonance Spectroscopy Imaging (MRSI) during pre-treatment, week 3 during radiation therapy, end of radiation therapy; will include standard gadolinium enhanced MRI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant temozolomide therapy, per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SIB + IMRT | Experimental | * Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
* 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
* Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
* Adjuvant Temozolomide Therapy for up to 12 cycles. Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Temozolomide; Behavioral: Functional Assessment of Cancer Therapy-Brain (FACT-Br); Radiation: Simultaneous Integrated Boost; Device: 3D MRSI |
| Group 2: SRS Boost + IMRT | Experimental | For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
* Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
* 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
* Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
* Adjuvant Temozolomide Therapy for up to 12 cycles. Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Temozolomide; Behavioral: Functional Assessment of Cancer Therapy-Brain (FACT-Br); Radiation: Stereotactic Radiosurgery Boost; Device: 3D MRSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Overall Survival (OS) in Study Patients
The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.
Measured: Up to 2 years
Secondary outcomes (4)
Rate of Progression-Free Survival (PFS) in Study Patients
Rate of progression-free survival in study participants. Progression-free survival (PFS) is defined as the time elapsed from the start of study treatment to the date of documented progression events. For progression-free patients (without progression events), PFS will be censored at the last date of documented PF status.
Measured: Up to 2 years
Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.
Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.
Measured: 2 years
Change in Quality of Life From Baseline in Study Participants
Change in quality of life during radiation and across the longitudinal progression-free interval compared to baseline. Change of quality of life will be assessed and scored via the FACT-Br behavioral questionnaire.
Measured: Up to 2 years
Patterns of Failure in Study Participants Post-Protocol Therapy
Patterns of Failure will be assessed by determining the number of failures that arise in-field compared to the number that arise out-of-field. In-field failure will be defined as those where greater than 80% of the recurrence volume was encompassed by the 95% prescription isodose line. In addition, we will also describe failures by three types: unifocal, multifocal and diffuse (multicentric including leptomeningeal dissemination).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Lack of Accrual/Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fazilat Ishkanian, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394665
- Sponsor's protocol ID
- 20140540
- Status last verified
- Nov 2016
- First submitted
- 16 Mar 2015
- Last updated
- 5 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dose Escalated, Targeted Radiation Therapy Using 3D Magnetic Resonance Spectroscopy Imaging (MRSI) in Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT02394665
- Acronym / sponsor ID
- 20140540
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Gliosarcoma, GBM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Accrual/Enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although clinical gains have been achieved in the past, these have been modest, with a majority of patients succumbing to local disease progression within 2 years. New strategies for treatment need to be identified which enhance local control above the current treatment regimen in order to achieve further clinical gains in this disease. Favorable early experience with magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic imaging can identify active tumor beyond standard MRI as well as high risk regions at risk for local failure. There is also clinical evidence that limited field dose escalation with either simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible and safe. Coupling these findings provide the rationale for this proposed Phase II trial designed to define efficacy and toxicity of the novel treatment approach of whole brain volumetric 3D MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM patients.
Detailed description
This phase II study will investigate efficacy and safety of volumetric 3D MRSI-directed treatment for newly diagnosed GBM patients. This study will enroll 48 patients in order to obtain at least 40 patients receiving RT and temozolomide. Depending on the size and number of HTVs, a patient will receive either simultaneous integrated boost (SIB) with IMRT (Group 1) or SRS boost followed by IMRT 1 week later (Group 2). Duration of enrollment will be 2 years and minimum follow-up will be 2 years.
The duration of treatment and follow-up will occur as follows:
- Six weeks of RT with concurrent Temozolomide treatment;
- 3D MRSI at week 3 and at the end of RT;
- 28 day break;
- Adjuvant treatment with Temozolomide administered daily on days 1-5 of each cycle, for up to 12 cycles (one cycle = 28 days) which will include standard gadolinium enhanced MRI and 3D MRSI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant Temozolomide;
- Active follow-up at least every three months for one year after the end of adjuvant Temozolomide treatment;
- After one year follow-up for survival will occur every three months for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: SIB + IMRT | Experimental | Radiation: Intensity Modulated Radiation Therapy, Drug: Temozolomide, Behavioral: Functional Assessment of Cancer Therapy-Brain (FACT-Br), Radiation: Simultaneous Integrated Boost, Device: 3D MRSI* Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks; * 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy; * Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points; * Adjuvant Temozolomide Therapy for up to 12 cycles. |
| Group 2: SRS Boost + IMRT | Experimental | Radiation: Intensity Modulated Radiation Therapy, Drug: Temozolomide, Behavioral: Functional Assessment of Cancer Therapy-Brain (FACT-Br), Radiation: Stereotactic Radiosurgery Boost, Device: 3D MRSIFor patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm: * Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks; * 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy; * Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points; * Adjuvant Temozolomide Therapy for up to 12 cycles. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically proven diagnosis of glioblastoma (WHO grade IV). Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.
- The tumor must have a supratentorial component
- Patients must have recovered from the effects of surgery, postoperative infection and other complications
- Karnofsky performance status > 70
- Age > 18 years
Key exclusion criteria (23 listed)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity or cervix are all permissible)
- Recurrent malignant glioma or evidence of leptomeningeal spread
- Metastases detected below the tentorium or beyond the cranial vault
- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation therapy fields
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 |
|---|---|---|
| Intensity Modulated Radiation TherapyAlso: IMRT, Fractionated RTIMRT treatment will consist of 60 Gy in 30 fractions to PTV 60 | Radiation | Group 1: SIB + IMRT, Group 2: SRS Boost + IMRT |
| TemozolomideAlso: Temodar, TemodalConcurrently during radiation therapy. Adjuvant therapy administered daily on days 1 - 5 for 12 cycles. One cycle = 28 days: * Concurrent during Radiation Therapy: 75 mg/m^2 orally for 6 weeks; * Post-radiation, adjuvant therapy: 150 mg/m^2 - 200 mg/m^2 orally daily on days 1 - 5 of each cycle. | Drug | Group 1: SIB + IMRT, Group 2: SRS Boost + IMRT |
| Functional Assessment of Cancer Therapy-Brain (FACT-Br)Also: FACT-BrFACT-Br Quality of Life (QOL) questionnaire to be completed by study patients as protocol specific timepoints | Behavioural | Group 1: SIB + IMRT, Group 2: SRS Boost + IMRT |
| Stereotactic Radiosurgery BoostAlso: SRS BoostPatients will undergo SRS boost in a single fraction dose prior to IMRT treatment: HTV Maximum dimension vs. Prescribed Dose to HTV: ≤ 20 mm = 21 Gy; 21 mm - 30 mm = 18 Gy; 31 mm - 40 mm = 15 Gy. | Radiation | Group 2: SRS Boost + IMRT |
| Simultaneous Integrated BoostAlso: SIBTreatment shall consist of 60 Gy in 30 fractions to planning target volume (PTV) 60 and 75 Gy in 30 fractions to PTV 75. | Radiation | Group 1: SIB + IMRT |
| 3D MRSIAlso: 3D Magnetic Resonance Spectroscopy ImagingThree Dimensional Magnetic Resonance Spectroscopy Imaging (MRSI) during pre-treatment, week 3 during radiation therapy, end of radiation therapy; will include standard gadolinium enhanced MRI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant temozolomide therapy, per protocol. | Device | Group 1: SIB + IMRT, Group 2: SRS Boost + IMRT |
Primary outcome
Rate of Overall Survival (OS) in Study Patients
Time frame: Up to 2 years
The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.
4 secondary outcomes
Rate of Progression-Free Survival (PFS) in Study Patients
Time frame: Up to 2 years
Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.
Time frame: 2 years
Change in Quality of Life From Baseline in Study Participants
Time frame: Up to 2 years
Patterns of Failure in Study Participants Post-Protocol Therapy
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fazilat Ishkanian, MD, PhD principal investigator
University of Miami
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 Intensity Modulated Radiation Therapy, Temozolomide and Functional Assessment of Cancer Therapy-Brain (FACT-Br) in people with Glioblastoma, run by University of Miami at 1 site in United States.
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 23 inclusion and 23 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: stopped early, as of the sponsor's last update on 5 Jan 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Overall Survival (OS) in Study Patients (time frame: Up to 2 years). 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 5 Jan 2017.