Adenocarcinoma of the ProstatePhase 3CTC-STOPNCT03327662
Utilising CTC Counts to Optimize Systemic Therapy of Metastatic Prostate Cancer
A Phase 3 study testing Active CTC Assessment in people with Adenocarcinoma of the Prostate, run by Institute of Cancer Research, United Kingdom at 4 sites in United Kingdom.
Trial summary
CTC-STOP is a multicentre prospective randomised controlled phase III trial for metastatic castration-resistant prostate cancer patients. This study will determine if serial CTC counts can be used as early markers of progression to direct early discontinuation of docetaxel chemotherapy in patients with mCRPC without… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Active CTC Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 11 Jan 2017to Apr 2020
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age ≥18 years
- Histologically confirmed diagnosis of adenocarcinoma of the prostate with availability of archival tumour tissue for molecular analyses (small cell prostate cancer is an exclusion); if no histological diagnosis has ever been acquired a fresh bone marrow trephine tumour biopsy confirming the presence of CRPC must be pursued.
- o Tumour tissue blocks will be requested for processing. Sections will be cut with the blocks then returned to the referring hospital. If the block is not available, at least ten tumour tissue sections (formalin-fixed paraffin-embedded) at 5 microns each will be requested.
- Metastatic castration-resistant disease with only bone metastases, confirmed by bone scan (within 4 weeks) or CT (within 6 weeks), of starting this trial (Cycle 1 Day 1). Patients with local recurrence, and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an exclusion.
- Systemic chemotherapy indicated for disease progression, defined as:
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- o Bone Scan Progression: Two or more new documented bone lesions over previous 6 months.
- AND/OR
- o Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm the rising PSA is required.
- Baseline laboratory values as stated below:
- Creatinine ≤1.5 x upper limit of normal (ULN)
- Bilirubin ≤1.0 x ULN
- SGOT (AST) and SGPT (ALT) ≤2.5x ULN
- Castrate serum testosterone level (<50 ng/dL-or-<1.7 nmol/L)
- ANC ≥1.5 x 109cells/L
- Platelet count ≥100 x 109/L
- PSA ≥ 5ng/mL
- CTC levels ≥ 5 cells / 7.5 mL
- Prior treatment with abiraterone and/or enzalutamide, discontinued due to disease progression.
- Patient willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (either agonists or antagonists) throughout the study, unless treated with bilateral orchiectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (see Appendix A2).
- At least 3 weeks should have elapsed since stopping any investigational agent at the time of randomisation. More than 4 weeks since completion of radiotherapy, other than when a single palliative fraction is administered when only a two week interval is required before trial treatment commencement.
- Patient recovered from any therapy-related toxicity to ≤ grade 2, (except alopecia, anaemia and any signs or symptoms of androgen deprivation therapy).
- Patient willing to comply with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Participants must be surgically sterile or must agree to use effective contraception during the period of the therapy and for 12 months after the last dose of study treatment. Effective contraception is defined as double barrier contraception (e.g. condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).
Who cannot join
- Received any prior cytotoxic chemotherapy as treatment for castration-resistant prostate cancer. Patients that have received chemotherapy for hormone-sensitive metastatic prostate cancer will be allowed onto the trial, if the patient merits retreatment with docetaxel and at least 12 months has elapsed since the patient has completed that previous docetaxel therapy.
- Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease <1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.
- Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomisation with the exception of the continuous LHRH analogues.
- History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. Brain imaging for asymptomatic patients is not required.
- Current symptomatic cord compression requiring surgery or radiation therapy. (Once the patient is successfully treated the patient will be considered eligible for the study).
- Active second malignancy (except non-melanoma skin or superficial bladder cancer) defined as requiring anticancer therapy or within the previous two years.
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- Serious medical conditions such as heart failure, myocardial infarction, pulmonary thromboembolism within 12 months; stroke or treatment of a major active infection within 3 months of randomisation, as well as any significant medical illness that in the opinion of the Investigator would preclude protocol therapy.
- Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
- Hypersensitivity to the active substance, to any of its excipients (including polysorbate 80) or to other taxanes.
- Concomitant vaccination with yellow fever vaccine
- Concomitant use of medicinal products that are strong CYP3A inducers
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Velindre Cancer Centre
Cardiff
Western General Hospital
Edinburgh
University College London Hospital
London
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: Utilising Circulating Tumour Cell (CTC) Counts to Optimize Systemic Therapy of Metastatic Prostate Cancer: CTC-STOP Trial
CTC-STOP is a multicentre prospective randomised controlled phase III trial for metastatic castration-resistant prostate cancer patients.
This study will determine if serial CTC counts can be used as early markers of progression to direct early discontinuation of docetaxel chemotherapy in patients with mCRPC without adversely impacting overall survival, when compared with standard approaches to guide treatment switch decisions.
Read the detailed description
Patients with metastatic castration-resistant prostate cancer will be randomised 1:1 to either control group (standard of care) or intervention group (CTC-guided treatment). All patients will commence first line chemotherapy with docetaxel three-weekly and will receive a minimum of 3 cycles of treatment before any recommendation to discontinue first-line docetaxel.
- Control Group (standard of care): patients will receive first line docetaxel until disease progression according to treating clinician or completion of 10 cycles. Patients and treating clinicians will not be disclosed to the results of CTC determinations.
- Intervention Group (CTC guided treatment): patients will receive first line docetaxel until progression by CTC, and/or disease progression according to treating clinician or completion of 10 cycles. CTC results will be available to the treating clinician to guide decision-making. A progressing CTC count on Day 1 will require confirmation with a second CTC count performed on Day 15 (-/+ 5 days) of that cycle. If a patient is found to have two successive CTC determinations showing progression by CTCs, the clinician will receive a recommendation to discontinue docetaxel on the following cycle.
The reasons of the treating clinician to discontinue docetaxel will be reported in both groups. Patients who discontinue first line docetaxel according to the criteria for each group will be switched to second line chemotherapy with cabazitaxel. After progression on cabazitaxel or completion of 10 cycles, patients will be followed up for survival every three months until end of study.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Active CTC Assessment
- Keywords
- Cabazitaxel, Docetaxel, Circulating Tumour Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CTC AssessmentOther
CTC Counts used to guide treatment switch
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Active CTC assessment: Patients will receive first line docetaxel until progression by CTC, and/or disease progression according to treating clinician or completion of 10 cycles. CTC results will be available to the treating clinician to guide decision-making. A progressing CTC count on Day 1 will require confirmation with a second CTC count performed on Day 15 (-/+ 5 days) of that cycle. If a patient is found to have two successive CTC determinations showing progression by CTCs, the clinician will receive a recommendation to discontinue docetaxel on the following cycle. Receives: Other: Active CTC Assessment |
| Control | No intervention | Patients will receive first line docetaxel until disease progression according to treating clinician or completion of 10 cycles. Patients and treating clinicians will not be disclosed to the results of CTC determinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
OS is defined as the time from the date of randomisation to the date of death (due to any cause). Patients alive at end of follow-up will be censored at the last documented date of follow-up.
An initial non-inferiority analysis will be conducted followed by a superiority analysis if non-inferiority is demonstrated
Measured: 2 years
Secondary outcomes (15)
CTC-guided switch rates
Proportion of patients in the intervention group that undergo a chemotherapy switch from docetaxel to cabazitaxel guided by CTC results that fulfil the pre-specified criteria for progression.
Measured: 2 years
CTC effects on chemotherapy
To determine if the study of serial CTC counts will decrease the administration of cytotoxic chemotherapy, number of cycles of chemotherapy in both groups will be reported.
Measured: 2 years
Toxicity burden assessment
Incidence of treatment-emergent adverse events (safety and tolerability) will be assessed throughout the treatment period using the NCI CTCAE v4.0 and summarised in tabular format. Reported toxicities will be coded using MedDRA (current version)
Measured: 2 years
Brief Pain Inventory
validated questionnaire that assesses pain severity (four items) and pain interference (11 items). Pain severity is measured through patients' rating of their level of current pain, average pain, least pain in the last 24 hours and worst pain in the last 24 hours, using an 11-point numerical rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 'Worst Pain' and 'Average Pain' items of the BPI-SF are often used in clinical trials to singly represent pain severity.
Measured: 2 years
The Functional Assessment of Cancer Therapy-Prostate (FACT-P)
FACT-P is a relevant, worldwide Patient reported outcome measure tool used for assessing the health-related quality of life in men with prostate cancer. The FACT-P will be used in this study as part of a wider Quality of Life analysis to compare both arms.
Measured: 2 years
EuroQoL Five Dimensions (EQ-5D)
EQ-5D is a self reported questionnaire measuring generic health status. EQ-5D will be used in this study as part of a wider Quality of Life analysis to compare both arms.
Measured: 2 years
Progression Free Survival
PFS will be measured from the date of randomisation to the date of death (due to any cause) or disease progression (As per PCWG2 criteria), whichever occurs first. Patients alive and progression-free at the last documented date of follow-up will be censored at that date.
Measured: 2 years
Radiographic Progression Free Survival (rPFS)
rPFS will be measured from randomisation to the occurrence of one of the following:
- Development of new nodal / soft tissue (inclusive of measurable soft tissue associated with lytic bone -metastases) lesions by CT as defined in RECIST 1.1 criteria, and/or
- Progression of bone disease by PCWG2 bone scan criteria and/or,
- Death of any cause
In case of progression by bone scan, the date of progression will be considered as the date of the first bone scan showing new lesions.
Measured: 2 years
Time to First Symptomatic Skeletal Related Event (SSRE)
The time to the first SSRE will be defined will be measured from the date of randomisation to the date of any of the following:
- First use of external-beam radiation therapy to relieve skeletal symptoms
- New symptomatic pathologic vertebral or non-vertebral bone fractures
- Spinal cord compression
- Tumour-related orthopaedic surgical intervention
Patients alive and free of SSRE at the last documented date of follow-up will be censored at that date.
Measured: 2 years
Time to CTC Progression
CTC progression will be based on serial CTC levels collected during the study. Time to CTC Progression will be defined as the time from randomisation to the time of first blood test showing progression by CTCs, defined by:
- Failure to achieve a 30% decline from Screening CTC counts (baseline) AND a failure to achieve a conversion from unfavourable (≥ 5 cells/7.5 mL) to favourable (< 5 cells/7.5 mL) count; or
- Conversion from favourable to unfavourable CTC counts after a previous CTC response; or
- A 30% increase in CTC count from nadir after a previous CTC response and an unfavourable CTC count (i.e. CTC ≥ 5 cells/7.5 mL).
An additional CTC count will be required to confirm progression. If confirmed, the date of the first CTC count meeting criteria for progression will be used as progression date.
Measured: 2 years
Circulating Tumour Cells (CTC) counts
Serial CTC levels collected during the study will be compared to evaluate the % CTC change from Screening (baseline). Change at any time point will be classified into response CTC (decline >30%), stable CTC (change between -30% and 30%) and progressive CTC (increase >30%).
The endpoint of interest for this study is the proportion of patients with a stable CTC count by 12-weeks (or earlier if treatment discontinued).
Measured: 2 years
Prostate Specific Antigen (PSA) Counts
PSA values will be measured at regular timepoints in the study. At each time point where PSA is measured, % change from baseline PSA value will be measured, maximum PSA decline at any time and decline after 12 weeks on 1st and 2nd line chemotherapy will be reported.
Measured: 2 years
Rate of CTC Response
CTC response is defined by:
- A conversion from unfavourable (>= 5 CTC/7.5 mL) to favourable (< 5 CTC/7.5 mL) CTC counts OR
- A 30% or more decrease in CTC counts from screening (baseline).
Measured: 2 years
Rate of Pain response
Pain response will be evaluated only in patients with a median BPI score of ≥2 and will be defined as a reduction of 2 points or more from baseline median BPI score without an increase in analgesic score maintained for 3 or more weeks.
Pain Progression Pain progression will be defined as an increase of at least two-points in the worst pain score over the mean baseline score (as defined by the baseline BPI), maintained for at least two consecutive measurements approximately 3-weeks apart.
Measured: 2 years
Health Economic assessment
A decision analytic model will be developed, modelling the CTC guided and comparator interventions. The model will analyse the most cost-effective strategy for the management of patients with progressive disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start11 Jan 2017
- Primary completionNov 2019
- Study completionApr 2020
Why it stopped: Underrecruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with CTC count \>5 CTC/7.5 mL at screening will be randomised 1:1 to either the control group (standard of care) or intervention group (CTC guided treatment). All patients will commence first line chemotherapy with docetaxel 75mg/m2 three-weekly and will receive a minimum of 3 cycles of treatment before any recommendation to discontinue first-line docetaxel.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer UK, University of Twente, Sanofi, Janssen, LP, Menarini Group
- Responsible party
- Sponsor
- Investigators
- Johann De Bono, MBChB FRCP MSc PhD, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327662
- Sponsor's protocol ID
- ICR-CTSU/2015/10054
- Acronym
- CTC-STOP
- Status last verified
- Jan 2021
- First submitted
- 10 Oct 2017
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilising Circulating Tumour Cell (CTC) Counts to Optimize Systemic Therapy of Metastatic Prostate Cancer: CTC-STOP Trial
- ClinicalTrials.gov ID
- NCT03327662
- Acronym / sponsor ID
- CTC-STOP / ICR-CTSU/2015/10054
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- Cabazitaxel, Docetaxel, Circulating Tumour Cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Underrecruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Prostate Cancer UK, University of Twente, Sanofi, Janssen, LP, Menarini Group
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 31 Oct 2017 (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.
CTC-STOP is a multicentre prospective randomised controlled phase III trial for metastatic castration-resistant prostate cancer patients.
This study will determine if serial CTC counts can be used as early markers of progression to direct early discontinuation of docetaxel chemotherapy in patients with mCRPC without adversely impacting overall survival, when compared with standard approaches to guide treatment switch decisions.
Detailed description
Patients with metastatic castration-resistant prostate cancer will be randomised 1:1 to either control group (standard of care) or intervention group (CTC-guided treatment). All patients will commence first line chemotherapy with docetaxel three-weekly and will receive a minimum of 3 cycles of treatment before any recommendation to discontinue first-line docetaxel.
- Control Group (standard of care): patients will receive first line docetaxel until disease progression according to treating clinician or completion of 10 cycles. Patients and treating clinicians will not be disclosed to the results of CTC determinations.
- Intervention Group (CTC guided treatment): patients will receive first line docetaxel until progression by CTC, and/or disease progression according to treating clinician or completion of 10 cycles. CTC results will be available to the treating clinician to guide decision-making. A progressing CTC count on Day 1 will require confirmation with a second CTC count performed on Day 15 (-/+ 5 days) of that cycle. If a patient is found to have two successive CTC determinations showing progression by CTCs, the clinician will receive a recommendation to discontinue docetaxel on the following cycle.
The reasons of the treating clinician to discontinue docetaxel will be reported in both groups. Patients who discontinue first line docetaxel according to the criteria for each group will be switched to second line chemotherapy with cabazitaxel. After progression on cabazitaxel or completion of 10 cycles, patients will be followed up for survival every three months until end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with CTC count >5 CTC/7.5 mL at screening will be randomised 1:1 to either the control group (standard of care) or intervention group (CTC guided treatment). All patients will commence first line chemotherapy with docetaxel 75mg/m2 three-weekly and will receive a minimum of 3 cycles of treatment before any recommendation to discontinue first-line docetaxel.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Active CTC AssessmentActive CTC assessment: Patients will receive first line docetaxel until progression by CTC, and/or disease progression according to treating clinician or completion of 10 cycles. CTC results will be available to the treating clinician to guide decision-making. A progressing CTC count on Day 1 will require confirmation with a second CTC count performed on Day 15 (-/+ 5 days) of that cycle. If a patient is found to have two successive CTC determinations showing progression by CTCs, the clinician will receive a recommendation to discontinue docetaxel on the following cycle. |
| Control | No intervention | –Patients will receive first line docetaxel until disease progression according to treating clinician or completion of 10 cycles. Patients and treating clinicians will not be disclosed to the results of CTC determinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Written informed consent.
- Age ≥18 years
- Histologically confirmed diagnosis of adenocarcinoma of the prostate with availability of archival tumour tissue for molecular analyses (small cell prostate cancer is an exclusion); if no histological diagnosis has ever been acquired a fresh bone marrow trephine tumour biopsy confirming the presence of CRPC must be pursued.
- o Tumour tissue blocks will be requested for processing. Sections will be cut with the blocks then returned to the referring hospital. If the block is not available, at least ten tumour tissue sections (formalin-fixed paraffin-embedded) at 5 microns each will be requested.
- Metastatic castration-resistant disease with only bone metastases, confirmed by bone scan (within 4 weeks) or CT (within 6 weeks), of starting this trial (Cycle 1 Day 1). Patients with local recurrence, and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an exclusion.
Key exclusion criteria (11 listed)
- Received any prior cytotoxic chemotherapy as treatment for castration-resistant prostate cancer. Patients that have received chemotherapy for hormone-sensitive metastatic prostate cancer will be allowed onto the trial, if the patient merits retreatment with docetaxel and at least 12 months has elapsed since the patient has completed that previous docetaxel therapy.
- Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease <1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.
- Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomisation with the exception of the continuous LHRH analogues.
- History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. Brain imaging for asymptomatic patients is not required.
- Current symptomatic cord compression requiring surgery or radiation therapy. (Once the patient is successfully treated the patient will be considered eligible for the study).
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 |
|---|---|---|
| Active CTC AssessmentCTC Counts used to guide treatment switch | Other | Interventional |
Primary outcome
Overall Survival
Time frame: 2 years
OS is defined as the time from the date of randomisation to the date of death (due to any cause). Patients alive at end of follow-up will be censored at the last documented date of follow-up. An initial non-inferiority analysis will be conducted followed by a superiority analysis if non-inferiority is demonstrated
15 secondary outcomes
CTC-guided switch rates
Time frame: 2 years
CTC effects on chemotherapy
Time frame: 2 years
Toxicity burden assessment
Time frame: 2 years
Brief Pain Inventory
Time frame: 2 years
The Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: 2 years
EuroQoL Five Dimensions (EQ-5D)
Time frame: 2 years
Progression Free Survival
Time frame: 2 years
Radiographic Progression Free Survival (rPFS)
Time frame: 2 years
Time to First Symptomatic Skeletal Related Event (SSRE)
Time frame: 2 years
Time to CTC Progression
Time frame: 2 years
Circulating Tumour Cells (CTC) counts
Time frame: 2 years
Prostate Specific Antigen (PSA) Counts
Time frame: 2 years
Rate of CTC Response
Time frame: 2 years
Rate of Pain response
Time frame: 2 years
Health Economic assessment
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Underrecruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
Johann De Bono, MBChB FRCP MSc PhD principal investigator
Institute of Cancer Research, United Kingdom
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active CTC Assessment in people with Adenocarcinoma of the Prostate, run by Institute of Cancer Research, United Kingdom at 4 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 25 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: stopped early, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Underrecruitment). Results are not available in the source record.
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.