Squamous Cell Carcinoma of the Oral CavityPhase 2INSPIRENCT02609386
IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
A Phase 2 study testing IRX-2, Cyclophosphamide and Indomethacin in people with Squamous Cell Carcinoma of the Oral Cavity, run by Brooklyn ImmunoTherapeutics, LLC at 22 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity
- What is being tested?
- IRX-2, Cyclophosphamide and Indomethacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 11 Jan 2016to 28 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed (histology or cytology) clinical Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip). Subjects must be staged using AJCC Cancer Staging Manual Edition 7.0 (appendices 1 and 2).
- Disease surgically resectable with curative intent
- Hematological function: hemoglobin >9 g/dL; lymphocyte count >0.50 x 109/L; neutrophil count >1.5 x 109/L; platelet count >100 x 109/L
- Hepatic function: serum albumin >3.0 g/dL; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <3x the upper limits of normal (ULN); alkaline phosphatase <2x the ULN
- Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN
- Calculated creatinine clearance > 50 mL/minute (Appendix 4)
Show all 11Show fewer
- At least 18 years of age
- Willing and able to give informed consent and adhere to protocol therapy
- Karnofsky performance status (KPS) >=70%
- Females of childbearing potential (not surgically sterile or less than 12 months post-menopausal) must be able and willing to use a highly effective form of pregnancy prevention from the time of screening, during the study and 30 days after last dose of study regimen. Males with a partner of childbearing potential must use condoms with spermicide from the date of screening to 30 days after their last dose of study regimen
- Negative urine/serum pregnancy test, if applicable
Who cannot join
- Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
- Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
- Live vaccines should ideally not be administered to any patients undergoing treatment with chemotherapy or immunotherapy, but if need be, they should be administered >4 months prior to the initiation of treatment or >4 months after the completion of all treatment
- Inactivated vaccines should precede the initiation of any study regimen and/or standard adjuvant therapy by at least 2 weeks, but preferably 4 weeks or longer
- Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
- Tumor of the oropharynx
Show all 32Show fewer
- Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with T4b cancer:
- involvement of pterygopalatine fossa, maxillary sinus, or facial skin;.
- gross extension of tumor to the skull base;
- pterygoid plate erosion;
- sphenoid bone or foramen ovale involvement;
- direct extension to involve prevertebral fascia;
- extension to superior nasopharynx or Eustachian tube;
- direct extension into the neck with involvement of the deep neck musculature (neck node fixation);
- suspected invasion (encasement) of the common or internal carotid arteries. Encasement will be assessed radiographically and will be defined as tumor surrounding the carotid artery 270º or greater;
- direct extension of neck disease to involve the external skin;
- direct extension to mediastinal structures;
- regional metastases to the supraclavicular neck (low level IVB or VB)
- Any investigational agent within the previous 30 days.
- Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days.
- Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulation or other platelet function inhibitors, that can not, in the documented opinion of the investigator, safely be interrupted from at least 2 days prior to the initiation of the study regimen until after surgical resection of the tumor.
- Symptomatic cardiopulmonary disease (including congestive heart failure and hypertension), coronary artery disease, serious arrhythmia or chronic lung disease. Patients with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for surgical treatment of their tumor need not be excluded
- Myocardial infarction within the last 3 months
- Distant metastases (M1 disease).
- Known infection with hepatitis B, hepatitis C, or HIV.
- Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).
- Clinically significant gastritis or peptic ulcer disease that would contraindicate the use of indomethacin.
- Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months.
- Allergy to ciprofloxacin (or other quinolones), acetylsalicylic acid, or indomethacin.
- Previous diagnosis of invasive cancer from which the individual is NOT disease-free AND that has required treatment within the past 5 years, except for superficial skin, cervical cancer in-situ, well-differentiated thyroid or early stage prostate or bladder cancer (i.e., treatment with curative intent and long term disease-free expectations).
- Prior axillary dissection.
- Breastfeeding women.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University - Winship Cancer Center
Atlanta, Georgia, 30322
University of Kentucky
Lexington, Kentucky, 40506
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Monter Cancer Center - North Shore LIJ
New Hyde Park, New York, 11040
Lenox Hill Hospital
New York, New York, 10075
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Providence Cancer Center
Portland, Oregon, 97209
Stanford University Medical Center
Stanford, California, 94305
Banner University Medical Center
Tucson, Arizona, 85742
Brazil7 sites
Hospital Erasto Gaertner
Curitiba
Instituto Goiano de Oncologia e Hematologia (INGOH)
Goiânia
Instituto do Câncer de Londrina
Londrina
Instituto Nacional do Cancer (INCA)
Rio de Janeiro
Hospital de Base de São José do Rio Preto
São José do Vale do Rio Preto
Instituto Brasileiro de Controle do Câncer
São Paulo
Instituto do Cancer do Estado de São Paulo - ICESP
São Paulo
United Kingdom1 site
Queen Elizabeth University Hospital Glasgow
Glasgow
About this study
Official title: A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.
Read the detailed description
This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of the oral cavity. Participants will be randomly assigned to receive either Regimen 1: IRX-2 + cyclophosphamide + indomethacin + zinc + omeprazole, or Regimen 2: cyclophosphamide + indomethacin + zinc + omeprazole.
The primary study hypothesis is that the Regimen 1 with IRX-2 prolongs event-free survival and overall survival when compared to Regimen 2 without IRX-2.
Subjects will be randomized to either Regimen 1 or Regimen 2 on a 2:1 basis and treated prior to surgery.
- Being tested
- IRX-2, Cyclophosphamide, Indomethacin, Zinc-containing multivitamin, Omeprazole
- Keywords
- Head and Neck Neoplasms, Immunotherapy, Cancer, Oral Cavity
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRX-2Biological
Also called Immunotherapy
Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
CyclophosphamideDrug
Also called Cytophosphane, Cytoxan
Method of Administration: Cyclophosphamide is administered once by IV
IndomethacinDrug
Also called NSAID, Indocin
Method of Administration: Indomethacin is administered orally for 21 days.
Zinc-containing multivitaminDietary supplement
Also called Zinc, Multi-vitamin
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
OmeprazoleDrug
Also called Proton pump inhibitor, Prilosec
Method of Administration: Omeprazole is administered orally for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Experimental | IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy. Receives: Biological: IRX-2; Drug: Cyclophosphamide; Drug: Indomethacin; Dietary Supplement: Zinc-containing multivitamin; Drug: Omeprazole |
| Regimen 2 | Active comparator | Regimen 1 but without IRX-2 Receives: Drug: Cyclophosphamide; Drug: Indomethacin; Dietary Supplement: Zinc-containing multivitamin; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)- Number of Participants With an Event
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.
Measured: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
EFS- Time to Event
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method.
Measured: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
Secondary outcomes (2)
Overall Survival (OS)- Number of Participants With an Event
OS was defined as the time from randomization to death due to any cause.
Measured: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
OS- Time to Event
OS was defined as the time from randomization to death due to any cause. Data for partipants who were alive at the end of the study were censored at the last known alive date. Median OS was estimated using the Kaplan-Meier method.
Measured: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start11 Jan 2016
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Oral CavityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooklyn ImmunoTherapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory T Wolf, MD, FACS, Principal investigator, University of Michigan Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609386
- Sponsor's protocol ID
- IRX-2 2015-A
- Acronym
- INSPIRE
- Status last verified
- Jan 2024
- First submitted
- 10 Sep 2015
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wolf GT, Fee WE Jr, Dolan RW, Moyer JS, Kaplan MJ, Spring PM, Suen J, Kenady DE, Newman JG, Carroll WR, Gillespie MB, Freeman SM, Baltzer L, Kirkley TD, Brandwein HJ, Hadden JW. Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Head Neck. 2011 Dec;33(12):1666-74. doi: 10.1002/hed.21660. Epub 2011 Jan 31.
PubMed 21284052Berinstein NL, Wolf GT, Naylor PH, Baltzer L, Egan JE, Brandwein HJ, Whiteside TL, Goldstein LC, El-Naggar A, Badoual C, Fridman WH, White JM, Hadden JW. Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Cancer Immunol Immunother. 2012 Jun;61(6):771-82. doi: 10.1007/s00262-011-1134-z. Epub 2011 Nov 6.
PubMed 22057678Wolf GT, Liu S, Bellile E, Sartor M, Rozek L, Thomas D, Nguyen A, Zarins K, McHugh JB; INSPIRE Trial Clinical Investigators. Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial. Oral Oncol. 2020 Dec;111:104928. doi: 10.1016/j.oraloncology.2020.104928. Epub 2020 Jul 29.
PubMed 32738599
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
- ClinicalTrials.gov ID
- NCT02609386
- Acronym / sponsor ID
- INSPIRE / IRX-2 2015-A
- Keywords
- Head and Neck Neoplasms, Immunotherapy, Cancer, Oral Cavity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Brooklyn ImmunoTherapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.
Detailed description
This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of the oral cavity. Participants will be randomly assigned to receive either Regimen 1: IRX-2 + cyclophosphamide + indomethacin + zinc + omeprazole, or Regimen 2: cyclophosphamide + indomethacin + zinc + omeprazole.
The primary study hypothesis is that the Regimen 1 with IRX-2 prolongs event-free survival and overall survival when compared to Regimen 2 without IRX-2.
Subjects will be randomized to either Regimen 1 or Regimen 2 on a 2:1 basis and treated prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Experimental | Biological: IRX-2, Drug: Cyclophosphamide, Drug: Indomethacin, Dietary Supplement: Zinc-containing multivitamin, Drug: OmeprazoleIRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy. |
| Regimen 2 | Active comparator | Drug: Cyclophosphamide, Drug: Indomethacin, Dietary Supplement: Zinc-containing multivitamin, Drug: OmeprazoleRegimen 1 but without IRX-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed (histology or cytology) clinical Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip). Subjects must be staged using AJCC Cancer Staging Manual Edition 7.0 (appendices 1 and 2).
- Disease surgically resectable with curative intent
- Hematological function: hemoglobin >9 g/dL; lymphocyte count >0.50 x 109/L; neutrophil count >1.5 x 109/L; platelet count >100 x 109/L
- Hepatic function: serum albumin >3.0 g/dL; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <3x the upper limits of normal (ULN); alkaline phosphatase <2x the ULN
- Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN
Key exclusion criteria (32 listed)
- Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
- Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
- Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
- Tumor of the oropharynx
- Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with T4b 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 |
|---|---|---|
| IRX-2Also: ImmunotherapyMethod of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. | Biological | Regimen 1 |
| CyclophosphamideAlso: Cytophosphane, CytoxanMethod of Administration: Cyclophosphamide is administered once by IV | Drug | Regimen 1, Regimen 2 |
| IndomethacinAlso: NSAID, IndocinMethod of Administration: Indomethacin is administered orally for 21 days. | Drug | Regimen 1, Regimen 2 |
| Zinc-containing multivitaminAlso: Zinc, Multi-vitaminMethod of Administration: Zinc-containing multivitamin is administered orally for 21 days. | Dietary supplement | Regimen 1, Regimen 2 |
| OmeprazoleAlso: Proton pump inhibitor, PrilosecMethod of Administration: Omeprazole is administered orally for 21 days | Drug | Regimen 1, Regimen 2 |
Primary outcome
Event-free Survival (EFS)- Number of Participants With an Event
Time frame: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.
EFS- Time to Event
Time frame: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method.
2 secondary outcomes
Overall Survival (OS)- Number of Participants With an Event
Time frame: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
OS- Time to Event
Time frame: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21284052Wolf GT, Fee WE Jr, Dolan RW, Moyer JS, Kaplan MJ, Spring PM, Suen J, Kenady DE, Newman JG, Carroll WR, Gillespie MB, Freeman SM, Baltzer L, Kirkley TD, Brandwein HJ, Hadden JW. Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Head Neck. 2011 Dec;33(12):1666-74. doi: 10.1002/hed.21660. Epub 2011 Jan 31.
- Background: PubMed 22057678Berinstein NL, Wolf GT, Naylor PH, Baltzer L, Egan JE, Brandwein HJ, Whiteside TL, Goldstein LC, El-Naggar A, Badoual C, Fridman WH, White JM, Hadden JW. Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Cancer Immunol Immunother. 2012 Jun;61(6):771-82. doi: 10.1007/s00262-011-1134-z. Epub 2011 Nov 6.
- Derived from this study: PubMed 32738599Wolf GT, Liu S, Bellile E, Sartor M, Rozek L, Thomas D, Nguyen A, Zarins K, McHugh JB; INSPIRE Trial Clinical Investigators. Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial. Oral Oncol. 2020 Dec;111:104928. doi: 10.1016/j.oraloncology.2020.104928. Epub 2020 Jul 29.
- Sponsor's websiteLink 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.
Gregory T Wolf, MD, FACS principal investigator
University of Michigan Hospitals
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IRX-2, Cyclophosphamide and Indomethacin in people with Squamous Cell Carcinoma of the Oral Cavity, run by Brooklyn ImmunoTherapeutics, LLC at 22 sites in 4 countries.
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 11 inclusion and 32 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Brazil, Canada, United Kingdom. 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 30 Jan 2024). 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?
Event-free Survival (EFS)- Number of Participants With an Event (time frame: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)). The study lists 2 primary outcomes in all. 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 NCT02609386, which also lists 3 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 30 Jan 2024.