Oropharyngeal CancerPhase 3CompARENCT04116047
CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)
A Phase 3 study testing Cisplatin, Durvalumab and Radiotherapy in people with Oropharyngeal Cancer, run by University of Birmingham at 38 sites in 2 countries.
Trial summary
CompARE is a multicentre, phase III open-label randomised controlled trial using an adaptive, Multi-Arm, Multi-Stage (MAMS) design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- Cisplatin, Durvalumab and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 785 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Jul 2015to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oropharyngeal squamous cell carcinoma (OPSCC) in base of tongue and tonsil with a Multidisciplinary Team (MDT) recommendation for treatment with definitive concurrent chemoradiotherapy
- All OPC T4 or N3 (HPV+ and HPV-) OR all HPV -ve (negative) OPC T1-T4, N1-N3 or T3-4, N0 OR HPV +ve (positive) OPC T1-T4 with N2b-N3 nodes AND who are smokers ≥ 10 pack years current or previous smoking history
- Minimum life expectancy of 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate renal function, glomerular filtration rate (GFR) >50ml/min calculated using Cockcroft-Gault formula
- Adequate bone marrow function (absolute neutrophil count (ANC) ≥1.5 x 109/L, haemoglobin ≥9.0g/dL and platelets ≥100 x 109/L)
Show all 15Show fewer
- Adequate liver function i.e. plasma bilirubin ≤1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤2.5 x ULN
- Prothrombin time (PT) ≤1.5 x ULN or International Normalised Ratio (INR) ≤1. 5
- Magnesium ≥ lower limit of normal
- No cancers in previous 5 years, except basal cell carcinoma of skin and cervical intra-epithelial neoplasia (CIN)
- Aged 18-70
- Written informed consent given for the trial
- Surgically resectable disease if being randomised to all four arms
- Females must either be of non-reproductive potential (i.e. post-menopausal by history: ≥55 years old and no menses for ≥1 year without an alternative medical cause; or history of hysterectomy, or history of bilateral tubal ligation or history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry
- Willingness to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow up
Who cannot join
- All T1-T2,N0 OPC (HPV +ve or HPV-ve)
- HPV positive patients who are:
- T1-T3, N0-N2c non-smokers T1-T3, N0-N2c smokers with ≤10 pack years or T1-T2, N0-N2a smokers with ≥10 pack years
- Unfit for chemoradiotherapy regimens
- Creatinine Clearance <50ml/min
- Treatment with any of the following, prior to randomisation:
Show all 27Show fewer
- Any Investigational Medicinal Products (IMP) within 30 days
- Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks
- Major surgery within 4 weeks
- History of allergic reactions to any of the IMPs and excipients used in this trial
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Women who are pregnant or breast-feeding. Women of child- bearing potential must have a negative pregnancy test performed within 7 days prior to randomisation
- Men or women who are not prepared to practise methods of contraception of proven efficacy during treatment and for 6 months following the end of treatment
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- Additional Exclusion Criteria for Arm 5 only:
- Any previous treatment with PD-L or PD-L1 inhibitor, including durvalumab
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid dose
- Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease e.g. colitis or Crohn's disease, diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with an active non-infectious pneumonitis
- History of primary immunodeficiency
- History of allogeneic organ transplant
- Known history of previous clinical diagnosis of tuberculosis
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab. Inactivated viruses, such as those in the influenza vaccine, are permitted
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United Kingdom36 sites
Aberdeen Royal Infirmary
Aberdeen, Aberdeen, AB25 2ZN
Royal United Hospital
Bath, BA1 3NG
Belfast City Hospital
Belfast, BT9 7AB
Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
Bristol Haematology and Oncology Centre
Bristol, Bristol, BS2 8ED
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Velindre Cancer Centre
Cardiff, Cardiff, CF14 2TL
Cheltenham General Hospital
Cheltenham, GL53 7AN
Colchester General Hospital
Colchester, Essex, CO4 5JL
Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
University Hospital Coventry
Coventry, West Midlands, CV2 2DX
Western General Hospital
Edinburgh, Edinburgh, EH4 2XU
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Leicester Royal Infirmary
Leicester, East Midlands, LE1 5WW
Aintree University Hospital
Liverpool, L9 7AL
North Middlesex Hospital
London, London, N18 1QX
Christie Hospital
Manchester, M20 4BX
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
James Cook University Hospital
Middlesbrough, North Yorkshire, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Nottingham City Hospital
Nottingham, Nottingham, NG5 1PB
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
Derriford Hospital
Plymouth
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
Queen's Hospital
Romford, Essex, RM7 0AG
Weston Park Hospital
Sheffield, South Yorkshire, S10 2SJ
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
Singleton Hospital
Swansea, Swansea, SA2 8QA
Musgrove Park Hospital
Taunton, TA1 5DA
Torbay Hospital
Torquay, TQ2 7AA
Newcross Hospital
Wolverhampton, West Midlands, WV10 OQP
York Hospital
York, North Yorkshire, YO31 8HE
Ireland2 sites
St Luke's Hospital
Dublin, Dublin 6
St James's Hospital
Dublin, Dublin 8
About this study
Official title: Phase III Randomised Controlled Trial Comparing Alternative Regimens for Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer
CompARE is a multicentre, phase III open-label randomised controlled trial using an adaptive, Multi-Arm, Multi-Stage (MAMS) design.
Read the detailed description
The CompARE Trial examines alternative regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer in an adult patient population. The aim is to assess whether escalated radiotherapy, adding surgery or immunotherapy will improve overall survival and quality of life in these patients.
- Conditions
- Oropharyngeal Cancer
- Being tested
- Cisplatin, Durvalumab, Radiotherapy
- Keywords
- Oropharyngeal cancer, HPV
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called CDDP, Platinol
DurvalumabDrug
Also called MEDI-4736, Imfinzi
RadiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (control): chemoradiotherapy | Active comparator | Concomitant chemoradiotherapy, 3-weekly cisplatin 100mg/m2 or weekly 40mg/m2 with Intensity Modulated Radiotherapy (IMRT) using 70 gray (Gy) in 35F(fractions) +/- neck dissection as indicated by clinical and radiological assessment 3-months post treatment. This is the international gold standard. Receives: Drug: Cisplatin; Procedure: Radiotherapy |
| Arm 5: Durvalumab + Arm 1 | Experimental | One dose of induction durvalumab 1500mg by intravenous (IV) infusion followed by arm 1 within four weeks. Within one-two weeks after the completion of arm 1, durvalumab 1500mg every four weeks will be initiated for a total of 6 months Receives: Drug: Cisplatin; Drug: Durvalumab; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Overall survival (OS)
defined as the interval in whole days between date of randomisation and date of death from any cause
Measured: from randomisation until date of death from any cause (follow-up until 8 years post-treatment)
Patient Event Free Survival (EFS)
defined as the interval in whole days between date of randomisation until date of progression/persistence/recurrence/death
Measured: From randomisation until date of progression/persistence/recurrence/death (follow-up until 8 years post-treatment)
Secondary outcomes (9)
Number of Acute (<3 months post-treatment) toxicity events experienced
Total number of acute (<3 months post-treatment) severe (grade 3-5) toxicity events experienced. Adverse events will be collected post-treatment and graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From date of randomisation until 2 year follow-up
Number of late (up to 2 years post-treatment) toxicity events experienced using CTCAE
Severe (grade 3-5) adverse events will be collected up to 2 years post randomisation, these events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and version 3.0 for scoring mucositis.
Measured: From date of randomisation until 2 year follow-up
Number of late (up to 2 years post-treatment) toxicity events experienced using RTOG
Late and severe toxicity events at 2 years post randomisation,will be collected and graded using Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring Criteria
Measured: From date of randomisation until 2 year follow-up
Head and neck specific quality of life at 2 years post-randomisation using EORTC C30
Patients will complete the European Organisation for Research and Treatment of Cancer (EORTC) C30 questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
Measured: From date of randomisation until 2 year follow-up
Head and neck specific Quality of Life at 2 years post-randomisation
Patients will complete the European Organisation for Research and Treatment of Cancer (EORTC) H\&N35 questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
Measured: From date of randomisation until 2 year follow-up
Swallowing outcomes assessed using MDADI Questionnaire at 24 months post-chemoradiotherapy
Patients will complete the M.D. Anderson Dysphagia Inventory (MDADI) Questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
Measured: From date of randomisation until 2 year follow-up
Levels of Percutaneous Endoscopic Gastrostomy (PEG) use
PEG use will be assessed at baseline, throughout treatment and during 2 year follow-up period
Measured: From date of randomisation until 2 year follow-up
Cost effectiveness of treatment as assessed using EuroQol Group (EQ-5D) questionnaire
Patients will complete the EuroQol Group (EQ-5D) questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
Measured: From date of randomisation until 2 year follow-up
Surgical complication rates in each arm for patients who require a neck dissection at 4 months following the 3 month post-chemoradiotherapy assessment scan.
Surgical complication rates will be assessed at trial visits if a neck dissection is required at 4 months post-chemotherapy
Measured: At 4 months following the 3 month post-chemoradiotherapy scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study startJul 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 785 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Cancer Trials Ireland
- Responsible party
- Sponsor
- Investigators
- Prof Mehanna, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116047
- Sponsor's protocol ID
- RG 14-093
- Other IDs
- 2014-003389-26, ISRCTN41478539, 2014
- Acronym
- CompARE
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2018
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomised Controlled Trial Comparing Alternative Regimens for Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04116047
- Acronym / sponsor ID
- CompARE / RG 14-093
- Conditions
- Oropharyngeal Cancer
- Keywords
- Oropharyngeal cancer, HPV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 785 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- AstraZeneca, Cancer Trials Ireland
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Oct 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.
CompARE is a multicentre, phase III open-label randomised controlled trial using an adaptive, Multi-Arm, Multi-Stage (MAMS) design.
Detailed description
The CompARE Trial examines alternative regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer in an adult patient population. The aim is to assess whether escalated radiotherapy, adding surgery or immunotherapy will improve overall survival and quality of life in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (control): chemoradiotherapy | Active comparator | Drug: Cisplatin, Procedure: RadiotherapyConcomitant chemoradiotherapy, 3-weekly cisplatin 100mg/m2 or weekly 40mg/m2 with Intensity Modulated Radiotherapy (IMRT) using 70 gray (Gy) in 35F(fractions) +/- neck dissection as indicated by clinical and radiological assessment 3-months post treatment. This is the international gold standard. |
| Arm 5: Durvalumab + Arm 1 | Experimental | Drug: Cisplatin, Drug: Durvalumab, Procedure: RadiotherapyOne dose of induction durvalumab 1500mg by intravenous (IV) infusion followed by arm 1 within four weeks. Within one-two weeks after the completion of arm 1, durvalumab 1500mg every four weeks will be initiated for a total of 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Oropharyngeal squamous cell carcinoma (OPSCC) in base of tongue and tonsil with a Multidisciplinary Team (MDT) recommendation for treatment with definitive concurrent chemoradiotherapy
- All OPC T4 or N3 (HPV+ and HPV-) OR all HPV -ve (negative) OPC T1-T4, N1-N3 or T3-4, N0 OR HPV +ve (positive) OPC T1-T4 with N2b-N3 nodes AND who are smokers ≥ 10 pack years current or previous smoking history
- Minimum life expectancy of 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate renal function, glomerular filtration rate (GFR) >50ml/min calculated using Cockcroft-Gault formula
Key exclusion criteria (27 listed)
- All T1-T2,N0 OPC (HPV +ve or HPV-ve)
- HPV positive patients who are:
- T1-T3, N0-N2c non-smokers T1-T3, N0-N2c smokers with ≤10 pack years or T1-T2, N0-N2a smokers with ≥10 pack years
- Unfit for chemoradiotherapy regimens
- Creatinine Clearance <50ml/min
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 |
|---|---|---|
| CisplatinAlso: CDDP, Platinol | Drug | Arm 1 (control): chemoradiotherapy, Arm 5: Durvalumab + Arm 1 |
| DurvalumabAlso: MEDI-4736, Imfinzi | Drug | Arm 5: Durvalumab + Arm 1 |
| Radiotherapy | Procedure or surgery | Arm 1 (control): chemoradiotherapy, Arm 5: Durvalumab + Arm 1 |
Primary outcome
Patient Overall survival (OS)
Time frame: from randomisation until date of death from any cause (follow-up until 8 years post-treatment)
defined as the interval in whole days between date of randomisation and date of death from any cause
Patient Event Free Survival (EFS)
Time frame: From randomisation until date of progression/persistence/recurrence/death (follow-up until 8 years post-treatment)
defined as the interval in whole days between date of randomisation until date of progression/persistence/recurrence/death
9 secondary outcomes
Number of Acute (<3 months post-treatment) toxicity events experienced
Time frame: From date of randomisation until 2 year follow-up
Number of late (up to 2 years post-treatment) toxicity events experienced using CTCAE
Time frame: From date of randomisation until 2 year follow-up
Number of late (up to 2 years post-treatment) toxicity events experienced using RTOG
Time frame: From date of randomisation until 2 year follow-up
Head and neck specific quality of life at 2 years post-randomisation using EORTC C30
Time frame: From date of randomisation until 2 year follow-up
Head and neck specific Quality of Life at 2 years post-randomisation
Time frame: From date of randomisation until 2 year follow-up
Swallowing outcomes assessed using MDADI Questionnaire at 24 months post-chemoradiotherapy
Time frame: From date of randomisation until 2 year follow-up
Levels of Percutaneous Endoscopic Gastrostomy (PEG) use
Time frame: From date of randomisation until 2 year follow-up
Cost effectiveness of treatment as assessed using EuroQol Group (EQ-5D) questionnaire
Time frame: From date of randomisation until 2 year follow-up
Surgical complication rates in each arm for patients who require a neck dissection at 4 months following the 3 month post-chemoradiotherapy assessment scan.
Time frame: At 4 months following the 3 month post-chemoradiotherapy scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Oropharyngeal Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
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.
Prof Mehanna principal investigator
University of Birmingham
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin, Durvalumab and Radiotherapy in people with Oropharyngeal Cancer, run by University of Birmingham at 38 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 15 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United Kingdom, Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Overall survival (OS) (time frame: from randomisation until date of death from any cause (follow-up until 8 years post-treatment)). 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?
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 7 May 2026.