Oropharyngeal CancerPEARLNCT03935672
PEARL PET-based Adaptive Radiotherapy Clinical Trial
A study testing PET-CT scans, Outlining the biological GTVs (bGTV_P and bGTV_iP) and Blood samples for cell-free DNA analysis in people with Oropharyngeal Cancer, run by Velindre NHS Trust at 3 sites in United Kingdom.
Trial summary
The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South Wales (Velindre Cancer Centre and Singleton Hospital, Swansea) and Bristol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- PET-CT scans, Outlining the biological GTVs (bGTV_P and bGTV_iP) and Blood samples for cell-free DNA analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Jul 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous cell carcinoma of the oropharynx
- Positive p16 Immunohistochemistry on local testing
- UICC TNM (8th edition) stage T1 - T3 N0 - N1 M0
- Multidisciplinary team (MDT) decision to treat with primary chemoradiotherapy
- Patients considered fit for radical treatment with primary chemoradiotherapy (including sufficient renal function (GFR>50ml/min)
- Aged 18 years or older
Show all 9Show fewer
- Not smoked in the last 2 years
- Written informed consent provided
- Patients with reproductive potential (male or female), who are sexually active during the duration of the trial consent to using a highly effective method of contraception for at least six months after the last dose of chemoradiotherapy. Effective forms of contraception are described in section 15.5.
Who cannot join
- Known HPV negative squamous cell carcinoma of the head and neck
- T1 - T3 tumours where primary treatment with concomitant chemo-radiotherapy is not considered appropriate
- T4 disease
- N2 (TMN8) nodal disease
- Distant metastatic disease
- Current smokers or smokers who have stopped within the past 2 years
Show all 11Show fewer
- Diabetes mellitus
- Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer
- Previous radiotherapy to the head and neck
- History of malignancy in the last 5 years, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix
- Tumour non-avid on PET-CT or not visible on cross sectional imaging
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Singleton Hospital
Swansea, Wales, SA2 8QA
About this study
Official title: PEARL: PET-based Adaptive Radiotherapy Clinical Trial
The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South Wales (Velindre Cancer Centre and Singleton Hospital, Swansea) and Bristol. The main aim is to see whether it is feasible to preform a positron emission tomography-computed tomography (PET-CT) scan after 2 weeks of radiotherapy and re-plan the radiotherapy based on this PET-CT scan, to re-distribute the dose of radiotherapy being delivered, so that a smaller area of normal tissues in the mouth and throat are treated to a high dose of radiotherapy.
Read the detailed description
PEARL is a prospective, interventional, non-randomised, phase II feasibility study for patients with good prognosis Human Papillomavirus (HPV)-associated oropharyngeal squamous cell cancer (OPSCC) who are suitable for treatment with concurrent chemo-radiotherapy (CCRT).
The incidence of oropharyngeal squamous cell carcinoma (OPSCC) caused by Human Papillomavirus (HPV) infection (HPV-positive OPSCC) is increasing in the United Kingdom. It tends to affect younger patients and has a better outcome than most other head and neck cancers.
A large proportion of patients diagnosed with HPV-positive OPSCC will undergo non-surgical treatment. This usually involves 6 to 7 weeks of chemo-radiotherapy, with chemotherapy being given weekly or during the first and fourth week of the radiotherapy course (CCRT). Many patients with HPV-positive OPSCC are cured of their disease but often have to live for several decades with the side effects of their treatment. Side effects from radiotherapy are usually caused because normal tissues surrounding the cancer receive radiation whilst the cancer itself is being treated.
Positron emission tomography-computed tomography (PET-CT) scans are able to look at the metabolic (or biological) activity of cells and are currently recommended in the UK for response assessment after a patient has completed radiotherapy for a head and neck cancer but, as far as we know, have not yet been used routinely to adapt radiotherapy according to the individual patient's response during radiotherapy.
PEARL will explore the feasibility of individually adapting the radiotherapy plan for each patient after 2 weeks of radical CCRT, based on biological changes in tumour activity seen on an interim FDG-PET-CT scan, carried out early on during a course of treatment. The aim is to reduce the dose of radiotherapy received by surrounding normal tissues to ultimately reduce toxicity.
The study will establish the progression free survival rate (PFS) in patients who receive biologically adapted radiotherapy. Furthermore, it will also explore whether changes seen on PET-CT scan during treatment correlate with outcome and with changes in potential blood-based biomarkers of response. Toxicity rates will be assessed, particularly the effect of treatment on swallowing function.
- Conditions
- Oropharyngeal Cancer
- Being tested
- PET-CT scans, Outlining the biological GTVs (bGTV_P and bGTV_iP), Blood samples for cell-free DNA analysis, Salivary samples for cell-free DNA analysis
- Keywords
- Oropharyngeal Cancer, Radiotherapy, HPV positive, Automated segmentation, Radiotherapy re-planning
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT scansProcedure or surgery
Patients will have three scans during the trial.
- The 1st scan (prePET) is a baseline diagnostic scan. The patient is in a thermoplastic shell and PET CT will be used by to define a bGTV_P. bGTV_P will then be used as an adjunct to help us delineate the GTV_P.
- The 2nd scan (iPET) takes place following 2 weeks (10 fractions) of chemo-radiotherapy. The patient is in a thermoplastic shell and the PET CT will be used to delineate the remaining avid disease (bGTV_iP).
- The 3rd scan takes place 3 months following the last dose of radiotherapy. It will be used to ascertain whether any avid disease remains and may inform the need for further treatment.
Outlining the biological GTVs (bGTV_P and bGTV_iP)Procedure or surgery
The biological GTVs (bGTV_P and bGTV_iP) will be automatically delineated by ATLAAS and verified manually by a nuclear medicine physician and a clinical oncologist. It will consist of the high FDG uptake volume based on visual assessment whilst using suitable windowing levels. Any differences in contouring will be settled either by the two doctors reaching a consensus or by a third doctor if differences between the first two cannot be resolved.
Blood samples for cell-free DNA analysisProcedure or surgery
In order to contribute to our understanding of how disease processes may be monitored in a less invasive and less morbid manner, we will be collecting blood and saliva samples prior to, during, and after the radical treatment of OPSCC in PEARL, to see if there is correlation with disease status and FDG-PET-CT response.
Salivary samples for cell-free DNA analysisProcedure or surgery
In order to contribute to our understanding of how disease processes may be monitored in a less invasive and less morbid manner, we will be collecting blood and saliva samples prior to, during, and after the radical treatment of OPSCC in PEARL, to see if there is correlation with disease status and FDG-PET-CT response.
| Study group | Role | What they receive |
|---|---|---|
| All trial participants | Other | Baseline plasma and saliva tests for future translational analysis
Baseline planning FDG PET CT scan
Patients will start their 6 weeks of CCRT within two to three weeks following the planning scans. Cisplatin chemotherapy will be administered. 33 daily fractions of radiotherapy will be delivered over 6 weeks.
A second FDG-PET-CT scan (iPET) and repeat plasma and saliva tests will be carried out after 2 weeks of CCRT (on RT days 9 - 12) and the iPET assessed for residual FDG-avid disease. The biological GTV will be re-outlined based on the residual avid region of the tumour on the second PET-CT (bGTV_iP)
At the end of treatment, plasma and saliva tests will be carried out at 4 weeks post treatment and again at the 3 month post-treatment PET-CT
Swallowing and QoL assessments will be repeated 4 weeks (+/- 2 weeks) after treatment and will be repeated at 6, 12 and 24 months post-treatment. The plasma and saliva samples will be repeated at 12 and 24 months Receives: Procedure: PET-CT scans; Procedure: Outlining the biological GTVs (bGTV_P and bGTV_iP); Procedure: Blood samples for cell-free DNA analysis; Procedure: Salivary samples for cell-free DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival at 2 years
To maintain a high progression free survival rate with biologically adapted radiotherapy in patients with good prognosis HPV positive OPSCC. To be certain that we are not having a negative impact on PFS by adapting the RT plan we will ensure that PFS is at least as high as expected after treatment with chemo-radiotherapy in patients with similarly staged HPV-positive OPSCC.
Measured: 2 years following enrolment
Secondary outcomes (11)
Monthly recruitment rate
As this is a feasibility study, recruitment will be monitored and monthly recruitment rate over 2 years will be presented.
Measured: End of 2 years recruitment period
To test if individualized, adaptive, biologically-based radiotherapy planning is feasible and results in a significant change in the radiotherapy plan.
Percentage reduction in mean dose to OAR (superior pharyngeal constrictor muscles, contralateral parotids, contralateral submandibular gland, salivary glands) as a result of PET-CT during treatment. Percentage change to PTV will also be presented.
Measured: 2 weeks (10 fractions) of chemo-radiotherapy
To test if individualized, adaptive, biologically-based radiotherapy planning results in a significant change in the radiotherapy plan.
Percentage reduction in mean dose to OAR (superior pharyngeal constrictor muscles, contralateral parotids, contralateral submandibular gland, salivary glands) as a result of PET-CT during treatment. Percentage change to PTV will also be presented.
Measured: 2 weeks (10 fractions) of chemo-radiotherapy
To maintain high complete response rates 3 months after treatment
The proportion of patients who are complete metabolic responders at 3 months as per PERCIST criteria will be presented.
Measured: 3 months post treatment
Acute toxicity rates
Cumulative acute CTCAE toxicity score percentages during and up to 3 months after treatment will be presented.
Measured: 3 months post treatment
Late toxicity rates
Water swallow test will be plotted over time, scores will be presented at 6, 12, 18 and 24 months.
Measured: 6, 12 and 24 months post treatment
Late toxicity rates
MDADI will be plotted over time, scores will be presented at 6, 12, 18 and 24 months.
Measured: 6, 12 and 24 months post treatment]
Late toxicity rates
QoL scores will be plotted over time, scores will be presented at 6, 12, 18 and 24 months.
Measured: 6, 12 and 24 months post treatment]
To assess the effect of treatment on swallowing function
Water swallow test scores will be plotted over time.
Measured: 3, 6, 12 and 24 months post treatment
To assess the effect of treatment on swallowing function
MDADI scores will be plotted over time.
Measured: 3, 6, 12 and 24 months post treatment
To assess the effect of treatment on swallowing function
QoL scores will be plotted over time.
Measured: 3, 6, 12 and 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jul 2019 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PEARL is a prospective, interventional, non-randomised, phase II feasibility study for patients with good prognosis Human Papillomavirus (HPV)-associated oropharyngeal squamous cell cancer (OPSCC) who are suitable for treatment with concurrent chemo-radiotherapy (CCRT).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Velindre NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lisette Nixon, Velindre NHS Trust
- Investigators
- Mererid Evans, Principal investigator, Velindre Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935672
- Sponsor's protocol ID
- 2018/VCC/0029
- Other IDs
- 242633
- Acronym
- PEARL
- Status last verified
- Apr 2019
- First submitted
- 3 Oct 2018
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEARL: PET-based Adaptive Radiotherapy Clinical Trial
- ClinicalTrials.gov ID
- NCT03935672
- Acronym / sponsor ID
- PEARL / 2018/VCC/0029
- Conditions
- Oropharyngeal Cancer
- Keywords
- Oropharyngeal Cancer, Radiotherapy, HPV positive, Automated segmentation, Radiotherapy re-planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Velindre NHS TrustOther government
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South Wales (Velindre Cancer Centre and Singleton Hospital, Swansea) and Bristol. The main aim is to see whether it is feasible to preform a positron emission tomography-computed tomography (PET-CT) scan after 2 weeks of radiotherapy and re-plan the radiotherapy based on this PET-CT scan, to re-distribute the dose of radiotherapy being delivered, so that a smaller area of normal tissues in the mouth and throat are treated to a high dose of radiotherapy.
Detailed description
PEARL is a prospective, interventional, non-randomised, phase II feasibility study for patients with good prognosis Human Papillomavirus (HPV)-associated oropharyngeal squamous cell cancer (OPSCC) who are suitable for treatment with concurrent chemo-radiotherapy (CCRT).
The incidence of oropharyngeal squamous cell carcinoma (OPSCC) caused by Human Papillomavirus (HPV) infection (HPV-positive OPSCC) is increasing in the United Kingdom. It tends to affect younger patients and has a better outcome than most other head and neck cancers.
A large proportion of patients diagnosed with HPV-positive OPSCC will undergo non-surgical treatment. This usually involves 6 to 7 weeks of chemo-radiotherapy, with chemotherapy being given weekly or during the first and fourth week of the radiotherapy course (CCRT). Many patients with HPV-positive OPSCC are cured of their disease but often have to live for several decades with the side effects of their treatment. Side effects from radiotherapy are usually caused because normal tissues surrounding the cancer receive radiation whilst the cancer itself is being treated.
Positron emission tomography-computed tomography (PET-CT) scans are able to look at the metabolic (or biological) activity of cells and are currently recommended in the UK for response assessment after a patient has completed radiotherapy for a head and neck cancer but, as far as we know, have not yet been used routinely to adapt radiotherapy according to the individual patient's response during radiotherapy.
PEARL will explore the feasibility of individually adapting the radiotherapy plan for each patient after 2 weeks of radical CCRT, based on biological changes in tumour activity seen on an interim FDG-PET-CT scan, carried out early on during a course of treatment. The aim is to reduce the dose of radiotherapy received by surrounding normal tissues to ultimately reduce toxicity.
The study will establish the progression free survival rate (PFS) in patients who receive biologically adapted radiotherapy. Furthermore, it will also explore whether changes seen on PET-CT scan during treatment correlate with outcome and with changes in potential blood-based biomarkers of response. Toxicity rates will be assessed, particularly the effect of treatment on swallowing function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PEARL is a prospective, interventional, non-randomised, phase II feasibility study for patients with good prognosis Human Papillomavirus (HPV)-associated oropharyngeal squamous cell cancer (OPSCC) who are suitable for treatment with concurrent chemo-radiotherapy (CCRT).
| Arm | Type | Receives |
|---|---|---|
| All trial participants | Other | Procedure: PET-CT scans, Procedure: Outlining the biological GTVs (bGTV_P and bGTV_iP), Procedure: Blood samples for cell-free DNA analysis, Procedure: Salivary samples for cell-free DNA analysisBaseline plasma and saliva tests for future translational analysis Baseline planning FDG PET CT scan Patients will start their 6 weeks of CCRT within two to three weeks following the planning scans. Cisplatin chemotherapy will be administered. 33 daily fractions of radiotherapy will be delivered over 6 weeks. A second FDG-PET-CT scan (iPET) and repeat plasma and saliva tests will be carried out after 2 weeks of CCRT (on RT days 9 - 12) and the iPET assessed for residual FDG-avid disease. The biological GTV will be re-outlined based on the residual avid region of the tumour on the second PET-CT (bGTV_iP) At the end of treatment, plasma and saliva tests will be carried out at 4 weeks post treatment and again at the 3 month post-treatment PET-CT Swallowing and QoL assessments will be repeated 4 weeks (+/- 2 weeks) after treatment and will be repeated at 6, 12 and 24 months post-treatment. The plasma and saliva samples will be repeated at 12 and 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed squamous cell carcinoma of the oropharynx
- Positive p16 Immunohistochemistry on local testing
- UICC TNM (8th edition) stage T1 - T3 N0 - N1 M0
- Multidisciplinary team (MDT) decision to treat with primary chemoradiotherapy
- Patients considered fit for radical treatment with primary chemoradiotherapy (including sufficient renal function (GFR>50ml/min)
Key exclusion criteria (11 listed)
- Known HPV negative squamous cell carcinoma of the head and neck
- T1 - T3 tumours where primary treatment with concomitant chemo-radiotherapy is not considered appropriate
- T4 disease
- N2 (TMN8) nodal disease
- Distant metastatic disease
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 |
|---|---|---|
| PET-CT scansPatients will have three scans during the trial. * The 1st scan (prePET) is a baseline diagnostic scan. The patient is in a thermoplastic shell and PET CT will be used by to define a bGTV_P. bGTV_P will then be used as an adjunct to help us delineate the GTV_P. * The 2nd scan (iPET) takes place following 2 weeks (10 fractions) of chemo-radiotherapy. The patient is in a thermoplastic shell and the PET CT will be used to delineate the remaining avid disease (bGTV_iP). * The 3rd scan takes place 3 months following the last dose of radiotherapy. It will be used to ascertain whether any avid disease remains and may inform the need for further treatment. | Procedure or surgery | All trial participants |
| Outlining the biological GTVs (bGTV_P and bGTV_iP)The biological GTVs (bGTV_P and bGTV_iP) will be automatically delineated by ATLAAS and verified manually by a nuclear medicine physician and a clinical oncologist. It will consist of the high FDG uptake volume based on visual assessment whilst using suitable windowing levels. Any differences in contouring will be settled either by the two doctors reaching a consensus or by a third doctor if differences between the first two cannot be resolved. | Procedure or surgery | All trial participants |
| Blood samples for cell-free DNA analysisIn order to contribute to our understanding of how disease processes may be monitored in a less invasive and less morbid manner, we will be collecting blood and saliva samples prior to, during, and after the radical treatment of OPSCC in PEARL, to see if there is correlation with disease status and FDG-PET-CT response. | Procedure or surgery | All trial participants |
| Salivary samples for cell-free DNA analysisIn order to contribute to our understanding of how disease processes may be monitored in a less invasive and less morbid manner, we will be collecting blood and saliva samples prior to, during, and after the radical treatment of OPSCC in PEARL, to see if there is correlation with disease status and FDG-PET-CT response. | Procedure or surgery | All trial participants |
Primary outcome
Progression free survival at 2 years
Time frame: 2 years following enrolment
To maintain a high progression free survival rate with biologically adapted radiotherapy in patients with good prognosis HPV positive OPSCC. To be certain that we are not having a negative impact on PFS by adapting the RT plan we will ensure that PFS is at least as high as expected after treatment with chemo-radiotherapy in patients with similarly staged HPV-positive OPSCC.
11 secondary outcomes
Monthly recruitment rate
Time frame: End of 2 years recruitment period
To test if individualized, adaptive, biologically-based radiotherapy planning is feasible and results in a significant change in the radiotherapy plan.
Time frame: 2 weeks (10 fractions) of chemo-radiotherapy
To test if individualized, adaptive, biologically-based radiotherapy planning results in a significant change in the radiotherapy plan.
Time frame: 2 weeks (10 fractions) of chemo-radiotherapy
To maintain high complete response rates 3 months after treatment
Time frame: 3 months post treatment
Acute toxicity rates
Time frame: 3 months post treatment
Late toxicity rates
Time frame: 6, 12 and 24 months post treatment
Late toxicity rates
Time frame: 6, 12 and 24 months post treatment]
Late toxicity rates
Time frame: 6, 12 and 24 months post treatment]
To assess the effect of treatment on swallowing function
Time frame: 3, 6, 12 and 24 months post treatment
To assess the effect of treatment on swallowing function
Time frame: 3, 6, 12 and 24 months post treatment
To assess the effect of treatment on swallowing function
Time frame: 3, 6, 12 and 24 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mererid Evans principal investigator
Velindre Cancer Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-CT scans, Outlining the biological GTVs (bGTV_P and bGTV_iP) and Blood samples for cell-free DNA analysis in people with Oropharyngeal Cancer, run by Velindre NHS Trust at 3 sites in United Kingdom.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Svobodova (02920687463, svobodovam@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival at 2 years (time frame: 2 years following enrolment). 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 2 May 2019.