Childhood Germ Cell TumorPhase 2NCT00432094
Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
A Phase 2 study testing carboplatin, etoposide and ifosfamide in people with Childhood Germ Cell Tumor and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant… Read more about this study
- Who is it for?
- Ages 10 to 69 years
- Conditions the study is for
- Childhood Germ Cell Tumor, Ovarian Cancer, Teratoma
- What is being tested?
- carboplatin, etoposide and ifosfamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2006to Mar 2021
- 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 10 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2 as defined by the International Germ Cell Cancer Consensus Classification. Patients with increasing tumor markers only (i.e. no imaging evidence of progressive disease) are eligible for transplant.
- Age: ≥ 10 years and < 70 years of age.
- Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for subject 10 - 15 years of age
- Life expectancy: Greater than 8 weeks.
- Patients must have normal organ function as defined below:
- Hematologic:
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- Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days or Aranesp for 21 days
- White blood cells (WBC) > 2.5 x 10^9/L with an absolute neutrophile count (ANC) > 1.5 x 10^9/L and off G-CSF or GM-CSF for 10 days or Neulasta for 21 days
- Platelets > 100 x 10^9/L without transfusion and/or a bone marrow cellularity of ≥ 20%
- Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min.
- Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper limit of normal. No history of severe prior or ongoing chronic liver disease.
- Cardiac: Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia. LVEF ≥45% by MUGA/ECHO.
- Pulmonary: Patients must have no significant obstructive airways disease (FEV1 must be ≥ 50% of predicted) and must have acceptable diffusion capacity (corrected DLCO > 50% of predicted).
- Patients with a history of CNS tumor involvement are eligible if they have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy), have recovered from or stabilization of the side effects associated with the therapy and have no evidence of progressive CNS disease at the time of enrollment.
Who cannot join
- Patients with serious uncontrolled infections will not be eligible.
- Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation. The drugs used in this study are pregnancy category D - clear evidence of risk in pregnancy.
- Pregnant and breast feeding women will not be eligible.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Additional Eligibility prior to Transplant Two:
- Total Collection of ≥ 4 x 10^6 CD34 cells/kg prior to transplant one
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- Transplant able to occur between day +30 and day +90 from transplant one
- Recovery of blood counts as demonstrated by:
- WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days
- Platelets > 50 x 10^9/L without transfusion in the prior 7 days
- Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min
- Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper limit of normal
- Infection: Patients with serious uncontrolled infections at the time of planned transplant will be excluded
- Patients with progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria by imaging techniques are not eligible to proceed to the second transplant. Tumor marker increase alone is not sufficient to diagnose disease progression.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival.
PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
Read the detailed description
OBJECTIVES:
Primary
- Determine overall survival (OS) of patients with germ cell tumors treated with tandem autologous stem cell transplantation with non-cross-resistant conditioning regimens.
Secondary
- Determine disease-free survival (DFS) of patients treated with this regimen.
- Determine the toxicity of tandem transplants
- Determine the time to engraftment of neutrophils and platelets in patients treated for each transplant
- Determine the number of patients unable to adequately mobilize sufficient peripheral blood stem cells (PBSC) for tandem transplantation.
- Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem transplantation.
- Compare OS and DFS of patients undergoing single vs tandem transplantation.
OUTLINE:
- Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients receive G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell collection is complete. Patients undergo stem cell collection beginning on day 5 of G-CSF administration and continuing for at least 3 collections until the collection goal is met.
- Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and continuing until stem cell collection is complete. Patients meeting the collection goal after PBSC mobilization via G-CSF alone or in combination with chemotherapy will undergo tandem autologous transplantation. If collection goal is not met but the patient has collected > or = 2 x 10^6 CD34 cells/kg, a single autologous transplant will be performed.
- Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until blood counts recover.
- Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later, patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days -6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover.
After completion of study treatment, patients are followed at 6, 9, and 12 months and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Childhood Germ Cell Tumor, Ovarian Cancer, Teratoma
- Being tested
- carboplatin, etoposide, ifosfamide, paclitaxel, thiotepa
- Keywords
- childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular yolk sac tumor and teratoma with seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor, testicular seminoma, stage IV extragonadal non-seminomatous germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Teratoma, Ovarian Germ Cell Cancer, Testicular Neoplasms, Seminoma, Endodermal Sinus Tumor, Carcinoma, Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Days -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes
etoposideDrug
Also called VP-16, Toposar
600mg/m^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
ifosfamideDrug
Also called Mitoxana, Ifex
2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
paclitaxelDrug
Also called Taxol
225 mg/m^2 intravenous over 3 hours on Day -7.
thiotepaDrug
Also called N,N'N'-triethylenethiophosphoramide
150mg/m^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
autologous hematopoietic stem cell transplantationProcedure or surgery
Also called PBSC
Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)
MesnaDrug
Also called Uromitexan®
2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
filgrastimBiological
Also called G-CSF
Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 2 Transplants/1 Transplant (Overall) | Experimental | 2 Transplants: Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.
1 Transplants:Patients with Germ cell tumors who receive one transplant only. Receives: Drug: carboplatin; Drug: etoposide; Drug: ifosfamide; Drug: paclitaxel; Drug: thiotepa; Procedure: autologous hematopoietic stem cell transplantation; Drug: Mesna; Biological: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Measured: 1 Year
Secondary outcomes (4)
Disease-free Survival (DFS)
The number of patients who survive without any signs of symptions of that cancer or any other cancer.
Measured: 1 Year
Engraftment of Platelets
Platelet engraftment is defined as 20,000/mm^3 (20 x 10^9/L) for 3 consecutive days unsupported by a platelet transfusion.
Measured: Day 100
Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells
Number of patients unable to achieve adequate stem cell mobilization, need to undergo one or tandem transplantation. Stem cell mobilization = A process in which certain drugs are used to cause the movement of stem cells from the bone marrow into the blood. The stem cells can be collected and stored. They may be used later to replace the bone marrow during a stem cell transplant.
Measured: Pre-Transplant
Engraftment of Neutrophils
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study start19 Dec 2006
- Primary completionMar 2021
- Study completionMar 2021
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 Childhood Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Najla El Jurdi, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432094
- Sponsor's protocol ID
- 2006LS032
- Other IDs
- UMN-MT2005-21, UMN-0608M90586
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2007
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT00432094
- Acronym / sponsor ID
- 2006LS032
- Conditions
- Childhood Germ Cell Tumor, Ovarian Cancer, Teratoma
- Keywords
- childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor with seminoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 19 Dec 2006 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 7 Feb 2007 (estimated)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival.
PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
Detailed description
OBJECTIVES:
Primary
- Determine overall survival (OS) of patients with germ cell tumors treated with tandem autologous stem cell transplantation with non-cross-resistant conditioning regimens.
Secondary
- Determine disease-free survival (DFS) of patients treated with this regimen.
- Determine the toxicity of tandem transplants
- Determine the time to engraftment of neutrophils and platelets in patients treated for each transplant
- Determine the number of patients unable to adequately mobilize sufficient peripheral blood stem cells (PBSC) for tandem transplantation.
- Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem transplantation.
- Compare OS and DFS of patients undergoing single vs tandem transplantation.
OUTLINE:
- Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients receive G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell collection is complete. Patients undergo stem cell collection beginning on day 5 of G-CSF administration and continuing for at least 3 collections until the collection goal is met.
- Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and continuing until stem cell collection is complete. Patients meeting the collection goal after PBSC mobilization via G-CSF alone or in combination with chemotherapy will undergo tandem autologous transplantation. If collection goal is not met but the patient has collected > or = 2 x 10^6 CD34 cells/kg, a single autologous transplant will be performed.
- Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until blood counts recover.
- Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later, patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days -6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover.
After completion of study treatment, patients are followed at 6, 9, and 12 months and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants.
| Arm | Type | Receives |
|---|---|---|
| 2 Transplants/1 Transplant (Overall) | Experimental | Drug: carboplatin, Drug: etoposide, Drug: ifosfamide, Drug: paclitaxel, Drug: thiotepa, Procedure: autologous hematopoietic stem cell transplantation, Drug: Mesna, Biological: filgrastim2 Transplants: Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. 1 Transplants:Patients with Germ cell tumors who receive one transplant only. |
Who may qualify
- Ages
- 10 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2 as defined by the International Germ Cell Cancer Consensus Classification. Patients with increasing tumor markers only (i.e. no imaging evidence of progressive disease) are eligible for transplant.
- Age: ≥ 10 years and < 70 years of age.
- Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for subject 10 - 15 years of age
- Life expectancy: Greater than 8 weeks.
- Patients must have normal organ function as defined below:
Key exclusion criteria (14 listed)
- Patients with serious uncontrolled infections will not be eligible.
- Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation. The drugs used in this study are pregnancy category D - clear evidence of risk in pregnancy.
- Pregnant and breast feeding women will not be eligible.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Total Collection of ≥ 4 x 10^6 CD34 cells/kg prior to transplant one
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 |
|---|---|---|
| carboplatinDays -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes | Drug | 2 Transplants/1 Transplant (Overall) |
| etoposideAlso: VP-16, Toposar600mg/m^2/day intravenously (IV) over 60 minutes on Days -6 through -3. | Drug | 2 Transplants/1 Transplant (Overall) |
| ifosfamideAlso: Mitoxana, Ifex2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4. | Drug | 2 Transplants/1 Transplant (Overall) |
| paclitaxelAlso: Taxol225 mg/m^2 intravenous over 3 hours on Day -7. | Drug | 2 Transplants/1 Transplant (Overall) |
| thiotepaAlso: N,N'N'-triethylenethiophosphoramide150mg/m^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 | Drug | 2 Transplants/1 Transplant (Overall) |
| autologous hematopoietic stem cell transplantationAlso: PBSCPeripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg) | Procedure or surgery | 2 Transplants/1 Transplant (Overall) |
| MesnaAlso: Uromitexan®2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4. | Drug | 2 Transplants/1 Transplant (Overall) |
| filgrastimAlso: G-CSFBeginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days. | Biological | 2 Transplants/1 Transplant (Overall) |
Primary outcome
Overall Survival (OS)
Time frame: 1 Year
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
4 secondary outcomes
Disease-free Survival (DFS)
Time frame: 1 Year
Engraftment of Platelets
Time frame: Day 100
Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells
Time frame: Pre-Transplant
Engraftment of Neutrophils
Time frame: Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- 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.
Najla El Jurdi, MD principal investigator
Masonic Cancer Center, University of Minnesota
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 carboplatin, etoposide and ifosfamide in people with Childhood Germ Cell Tumor and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota 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 14 inclusion and 14 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 17 May 2022. 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 17 May 2022). 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?
Overall Survival (OS) (time frame: 1 Year). 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 17 May 2022.