Non-HPV Locally Advanced Head and Neck CancerPhase 2TRYHARDNCT01711658
TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
A Phase 2 study testing IMRT, Cisplatin and Lapatinib in people with Non-HPV Locally Advanced Head and Neck Cancer, run by Radiation Therapy Oncology Group at 16 sites in 2 countries.
Trial summary
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-HPV Locally Advanced Head and Neck Cancer
- What is being tested?
- IMRT, Cisplatin and Lapatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 15 Mar 2013to 21 Sep 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
- Patients must have histologically or cytologically confirmed diagnosis (from primary lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or larynx (For patients with oropharynx primary, the tumor must be negative for p16 by immunohistochemistry).
- Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3 p16 negative oropharynx cancer or T1-2 any N+ hypopharynx cancer) including no distant metastases.
- History/Physical examination by a Radiation Oncologist and Medical oncologist prior to entering the study.
- Examination by an ears, nose, throat (ENT) or Head \& Neck Surgeon including laryngopharyngoscopy prior to entering the study.
- Patients must have a chest CT scan, or positron emission tomography (PET)/CT scan to rule out metastatic disease
- Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor site and neck nodes prior to entering the study.
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- Patients must have an EKG and echocardiogram (ECHO) or multigated acquisition (MUGA) scan prior to entering the study.
- Patients must have Zubrod Performance Status of 0-1.
- Patients must be ≥ 18 years of age.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl
- Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
- Total bilirubin < 2 x the institutional upper limit of normal
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional upper limit of normal
- Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
- Women of childbearing potential must have a negative pregnancy test prior to registration.
- Patients of reproductive potential must practice effective contraception while on study and for at least 60 calendar days following treatment.
- All patients must sign an informed consent prior to enrollment.
- Patients must comply with the treatment plan and follow-up schedule.
Who cannot join
- Patients with simultaneous primaries or bilateral tumors.
- Patients who have had gross total excision of the primary tumor.
- Patients with initial surgical treatment, radical or modified neck dissection.
- Patients who received prior systemic chemotherapy for the study cancer.
- Patients who received prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
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- Prior allergic reaction to the study drugs.
- Patients who have had prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER2) pathway.
- Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment);
- Pregnant women or sexually active patients not willing or able to use medically acceptable forms of contraceptive method while on treatment.
- Patients with severe, active co-morbidity, defined as follows:
- Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Left ventricular ejection fraction < 45%
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 calendar days prior to registration
- Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Emory University
Atlanta, Georgia, 30308
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas Southwestern Medical School
Dallas, Texas, 75390
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of California, San Diego
La Jolla, California, 92093
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale University
New Haven, Connecticut, 06520
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
Sutter General Hospital
Sacramento, California, 95816
University of California San Francisco
San Francisco, California, 94143
Canada1 site
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6
About this study
Official title: TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV).
- Being tested
- IMRT, Cisplatin, placebo, Lapatinib
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
Intensity modulated radiation therapy (IMRT), 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
CisplatinDrug
100 mg/m^2 administered intravenously on days 8 and 29
placeboDrug
1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
LapatinibDrug
1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
| Study group | Role | What they receive |
|---|---|---|
| IMRT + cisplatin + placebo | Placebo comparator | Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo Receives: Radiation: IMRT; Drug: Cisplatin; Drug: placebo |
| IMRT + cisplatin + lapatinib | Active comparator | IMRT with cisplatin and lapatinib Receives: Radiation: IMRT; Drug: Cisplatin; Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Alive Without Progression (Progression-free Survival)
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred after 67 progressions or deaths were reported.
Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Secondary outcomes (9)
Percentage of Participants Alive (Overall Survival)
An event for overall survival is death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants With Distant Metastases
Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
Measured: From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants Who Complied With Protocol Treatment
Compliance with protocol treatment is defined as "per protocol" or "acceptable variation" per study chair review for IMRT, cisplatin, pre-IMRT lapatinib/placebo, concurrent lapatinib/placebo, and maintenance lapatinib/placebo. Rates of treatment compliance were compared between groups by a 2-sided Fisher's exact test.
Measured: From start of treatment to end of treatment (approximately 5 months from randomization).
Percentage of Participants With Local-regional Progression
Failure for local-regional control endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Failure rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Performance Status Scale for Head & Neck Cancer.
Measured: 3 months, 1 year, and 2 years
Functional Assessment of Cancer Therapy - Head & Neck.
Measured: 3 months, 1 year, and 2 years.
University of Michigan Xerostomia-Related Quality of Life Scale.
Measured: 3 months, 1 year, and 2 years.
HER2, EGFR, EMT as Biomarkers of Response.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start15 Mar 2013
- Primary completion1 Dec 2020
- Study completion21 Sep 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 Non-HPV Locally Advanced Head and Neck CancerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline, Novartis
- Responsible party
- Sponsor
- Investigators
- Stuart Wong, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711658
- Sponsor's protocol ID
- RF-3501
- Other IDs
- LAP116153
- Acronym
- TRYHARD
- Status last verified
- Oct 2021
- First submitted
- 16 Oct 2012
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
PubMed 20530316Harrington K. et al. Phase II study of oral Lapatinib, a dual-tyrosine kinase inhibitor, combined with chemoradiotherapy (CRT) in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). J Clin Oncol. 28:15s, 2010 suppl. Abstract 5505. GSK study 884
Wong SJ, Torres-Saavedra PA, Saba NF, Shenouda G, Bumpous JM, Wallace RE, Chung CH, El-Naggar AK, Gwede CK, Burtness B, Tennant PA, Dunlap NE, Redman R, Stokes WA, Rudra S, Mell LK, Sacco AG, Spencer SA, Nabell L, Yao M, Cury FL, Mitchell DL, Jones CU, Firat S, Contessa JN, Galloway T, Currey A, Harris J, Curran WJ Jr, Le QT. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non-Human Papillomavirus Head and Neck Carcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1565-1573. doi: 10.1001/jamaoncol.2023.3809.
PubMed 37768670
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
- ClinicalTrials.gov ID
- NCT01711658
- Acronym / sponsor ID
- TRYHARD / RF-3501
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- GlaxoSmithKline, Novartis
- Study start
- 15 Mar 2013 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Posted 29 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT + cisplatin + placebo | Placebo comparator | Radiation: IMRT, Drug: Cisplatin, Drug: placeboIntensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo |
| IMRT + cisplatin + lapatinib | Active comparator | Radiation: IMRT, Drug: Cisplatin, Drug: LapatinibIMRT with cisplatin and lapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed diagnosis (from primary lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or larynx (For patients with oropharynx primary, the tumor must be negative for p16 by immunohistochemistry).
- Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3 p16 negative oropharynx cancer or T1-2 any N+ hypopharynx cancer) including no distant metastases.
- History/Physical examination by a Radiation Oncologist and Medical oncologist prior to entering the study.
- Examination by an ears, nose, throat (ENT) or Head \& Neck Surgeon including laryngopharyngoscopy prior to entering the study.
- Patients must have a chest CT scan, or positron emission tomography (PET)/CT scan to rule out metastatic disease
Key exclusion criteria (18 listed)
- Patients with simultaneous primaries or bilateral tumors.
- Patients who have had gross total excision of the primary tumor.
- Patients with initial surgical treatment, radical or modified neck dissection.
- Patients who received prior systemic chemotherapy for the study cancer.
- Patients who received prior radiotherapy to the region of the study cancer that would result 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 |
|---|---|---|
| IMRTIntensity modulated radiation therapy (IMRT), 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy | Radiation | IMRT + cisplatin + lapatinib, IMRT + cisplatin + placebo |
| Cisplatin100 mg/m^2 administered intravenously on days 8 and 29 | Drug | IMRT + cisplatin + lapatinib, IMRT + cisplatin + placebo |
| placebo1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT | Drug | IMRT + cisplatin + placebo |
| Lapatinib1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT | Drug | IMRT + cisplatin + lapatinib |
Primary outcome
Percentage of Participants Alive Without Progression (Progression-free Survival)
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred after 67 progressions or deaths were reported.
9 secondary outcomes
Percentage of Participants Alive (Overall Survival)
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants With Distant Metastases
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
Time frame: From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants Who Complied With Protocol Treatment
Time frame: From start of treatment to end of treatment (approximately 5 months from randomization).
Percentage of Participants With Local-regional Progression
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Performance Status Scale for Head & Neck Cancer.
Time frame: 3 months, 1 year, and 2 years
Functional Assessment of Cancer Therapy - Head & Neck.
Time frame: 3 months, 1 year, and 2 years.
University of Michigan Xerostomia-Related Quality of Life Scale.
Time frame: 3 months, 1 year, and 2 years.
HER2, EGFR, EMT as Biomarkers of Response.
Time frame: End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20530316Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
- BackgroundHarrington K. et al. Phase II study of oral Lapatinib, a dual-tyrosine kinase inhibitor, combined with chemoradiotherapy (CRT) in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). J Clin Oncol. 28:15s, 2010 suppl. Abstract 5505. GSK study 884
- Derived from this study: PubMed 37768670Wong SJ, Torres-Saavedra PA, Saba NF, Shenouda G, Bumpous JM, Wallace RE, Chung CH, El-Naggar AK, Gwede CK, Burtness B, Tennant PA, Dunlap NE, Redman R, Stokes WA, Rudra S, Mell LK, Sacco AG, Spencer SA, Nabell L, Yao M, Cury FL, Mitchell DL, Jones CU, Firat S, Contessa JN, Galloway T, Currey A, Harris J, Curran WJ Jr, Le QT. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non-Human Papillomavirus Head and Neck Carcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1565-1573. doi: 10.1001/jamaoncol.2023.3809.
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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.
Stuart Wong, MD principal investigator
Medical College of Wisconsin
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT, Cisplatin and Lapatinib in people with Non-HPV Locally Advanced Head and Neck Cancer, run by Radiation Therapy Oncology Group at 16 sites in 2 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 21 inclusion and 18 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 29 Nov 2021). 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?
Percentage of Participants Alive Without Progression (Progression-free Survival) (time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 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 NCT01711658, 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 17 Oct 2023.