Prostatic Cancer, Castration-ResistantPhase 3PEACE8NCT06276465
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
A Phase 3 study testing Darolutamide 300 mg, Stereotactic body radiation therapy and Androgen deprivation therapy in people with Prostatic Cancer, Castration-Resistant, run by UNICANCER at 4 sites in France.
Trial summary
In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Cancer, Castration-Resistant
- What is being tested?
- Darolutamide 300 mg, Stereotactic body radiation therapy and Androgen deprivation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Oct 2024to 7 Oct 2032
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
- Patients aged ≥18 years.
- Patient with histologically confirmed of adenocarcinoma prostate cancer without small cell or pure endocrine features.
- Patient with a history of local treatment with curative intent for localised prostate cancer, including surgery or radiotherapy.
- Patients with castration resistant prostate cancer, defined as either:
- An increasing PSA level, confirmed in 3 consecutive assessments performed at least 1 week apart. This despite androgen deprivation therapy and castrate levels of testosterone.
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- Tumour progression of soft tissue according to the response criteria in solid tumours (RECIST) version (v)1.1.
- Tumour progression on bone scan, according to PCWG3 criteria.
- N.B. The two latter conditions only apply to the M1CRPC population.
- Detection of 1 to 5 metastatic sites (pelvic lymph nodes included) on new generation PET using either choline, fluciclovine, or PSMA as tracer.
- All metastatic sites must be amenable to stereotactic radiation therapy.
- Patient with normal haematological function: absolute neutrophil count (ANC) >1.0 x 10⁹/L, platelets count ≥100 x 10⁹/L, and haemoglobin ≥9.0 g/dL.
- Patient with normal liver function with total bilirubin ≤1.5 upper limit of normal (ULN) (unless documented Gilbert's syndrome), aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 ULN (≤5 ULN in the presence of liver metastases).
- Adequate liver function with bilirubin <3 mg/dL and albumin >2.5 g/dL.
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg, as documented at baseline. Patients with hypertension are eligible if their hypertension is controlled and they meet all other eligibility criteria.
- Adequate kidney function with a creatinine clearance >30 mL/min (Cockcroft-Gault).
- Patient with Eastern Cooperative Oncology group (ECOG) performance status (PS) ≤1.
- Patient is willing to use contraceptive during and for at least 1 week after discontinuing darolutamide.
- Patient affiliated to the social security system (or equivalent according to local regulations for participation in clinical trials).
- Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
Who cannot join
- Patient previously treated for metastatic prostate cancer with a novel hormonal agent (NHA), a CYP17 inhibitor, ketoconazole, chemotherapy, or immunotherapy.
- A history of cancer, other than the prostate cancer under study, within the 3 years prior to study inclusion, excluding cured localised cancer such as non-melanomatous skin cancer and non-muscle invasive bladder cancer.
- Presence of an uncontrolled disease or affection that according to the investigator will hinder compliance with the trial procedures or requires hospitalisation.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) A at screening.
- Patients with known allergy or severe hypersensitivity to the study treatment or any of its excipients.
- Inability to swallow oral medications.
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- Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.
- Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Patients participating in another therapeutic trial within the 30 days prior to randomisation.
- Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.
- Person deprived of their liberty or under protective custody or guardianship.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Groupe Hospitalier Bretagne Sud
Lorient, 56322
Guillaume BERA, MD, g.bera@ghbs.bzh
Guillaume BERA, MD
- Recruiting
Centre Azuréen de Cancérologie
Mougins, 06250
Philippe RONCHIN, MD, ronchinp@yahoo.fr
Philippe RONCHIN, MD
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Thomas REYNAUD, MD, thomas.reynaud@chu-st-etienne.fr
Thomas REYNAUD, MD
- Recruiting
Gustave Roussy Cancer Campus
Villejuif, 94805
Ronan FLIPPOT, MD, RONAN.FLIPPOT@gustaveroussy.fr
Ronan FLIPPOT, MD
About this study
Official title: Combination of Darolutamide and Stereotactic Body Radiation Therapy in Patients With Castration Resistant Prostate Cancer and Oligometastases on Functional Imaging
In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.
In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.
Read more
An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.
The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.
The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide.
Read the detailed description
PEACE 8 is a phase III open-label, randomised (patients are randomly assigned to treatment), international, multicentre trial, evaluating the benefit of adding SBRT to darolutamide for treating patients with oligometastatic CRPC.
Eligible patients will be randomised into either an experimental group receiving darolutamide + SBRT or a control group receiving darolutamide. In both arms, all patients will receive continuous castration (ADT) during the trial course.
Patients' participation in the trial will not exceed 60 months after randomisation, including a maximum treatment duration of 60 months and follow-up up to 60 months after randomisation.
After signing the consent form, patients will enter the pre-inclusion period (before the start of treatment), during which the investigator will carried out all the tests required to assess their eligibility, including demographic data collection, tumour evaluation, and clinical and biological assessments.
Patients will receive doralutamide until disease progression or unacceptable toxicity for a maximum of 5 years after the start of treatment.
To receive treatment, the patient will need to go to hospital, where, at each visit, the medical team will conduct medical examinations before administering the treatment to assess the patient's general state of health and tolerance to the treatment.
- Conditions
- Prostatic Cancer, Castration-Resistant
- Being tested
- Darolutamide 300 mg, Stereotactic body radiation therapy, Androgen deprivation therapy
- Keywords
- Phase 3, International, Multicentric, Randomised, Stereotactic body radiation therapy (SBRT), PET-PSMA, mCRPC, nmCRPC, CRPC, oligometastases, functional imaging, darolutamide
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide 300 mgDrug
Also called Nubeqa
2 tablets of 300 mg twice daily (=1200 mg/day) up to 5 years from randomisation
Stereotactic body radiation therapyRadiation
Also called SBRT
Over one week,30 Gy in 3 fractions of 10 Gy
Androgen deprivation therapyDrug
Also called ADT
Continuous ADT during the study course. The choice of ADT is left to the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| ADT + darolutamide | Active comparator | Up to 5 years of treatment Receives: Drug: Darolutamide 300 mg; Drug: Androgen deprivation therapy |
| ADT + darolutamide + SBRT | Experimental | Up to 5 years of treatment Receives: Drug: Darolutamide 300 mg; Radiation: Stereotactic body radiation therapy; Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-free survival (rPFS)
The radiographic Progression-free survival is defined as the time interval between the randomisation and radiographic disease progression with conventional imaging (CT-scan or bone-scan), or death due to any cause, whichever occurs first.
Measured: From randomization to disease progression or death, up to 5 years.
Secondary outcomes (10)
Time to treatment failure (TTF)
The time to treatment failure is defined as the time interval between randomisation and the discontinuation of darolutamide, irrespective of the reason for discontinuation.
Measured: From randomization to discontinuation of darolutamide, up to 5 years
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Measured: From randomization to death from any cause, up to 5 years.
Prostate cancer-specific survival
The prostate cancer-specific survival is defined as the time interval between randomisation and the date of death due to prostate cancer.
Measured: From randomization to death due to prostate cancer, up to 5 years.
Time to PSA progression
The time to PSA progression is defined as the time interval between the date of randomisation and the date of PSA progression. PSA progression is defined, in accordance with the PCWG3 guidelines which retained the PCWG2 definition (2007 guidelines).
Measured: From randomization to PSA progression, up to 5 years.
Biochemical response rate
The biochemical response rate is defined as the proportion of patients with a decrease in PSA levels of ≥50% from baseline levels.
Measured: Throughout study completion, up to 5 years.
Time to next symptomatic skeletal event (SSE)
The time to next symptomatic skeletal event is defined as the time interval from randomisation until the first occurrence of a symptomatic fracture, bone radiation (for pain or neurological complication), bone surgery (for pain or neurological complication), or spinal cord compression.
Measured: Time from randomization to the first symptomatic skeletal event, up to 5 years.
Time to pain progression
The time to pain progression is defined as the time interval from randomisation until the first occurrence of any of the following:
- Increase of ≥2 points, from baseline, in question 3 of the Brief Pain Inventory-Short Form (BPI-SF) questionnaire (item related to the worst pain in the last 24 hours).
- Initiation of opioid treatment for cancer pain.
- Increase in the use of opioid treatment of ≥30% in terms of frequency of use or cumulative dose.
Measured: Time from randomization to the first occurence of pain progression, up to 5 years.
Safety/tolerance
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: Throughout study completion, up to 5 years.
Functional Assessment of CAncer Therapy - Prostate (FACT-P)
The FACT-P is a self-assessment questionnaire to estimate the health-related quality of life in men with prostate cancer. This questionnaire, composed of 39 items consists of four subscales: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), Functional Well-Being (7 items), and prostate cancer subscale (12 items). Subscales are rated on 5-point Likert-type scale (from 0 = "Not at all" to 4 = "Very much"). For all subscales, a higher score represents better quality of life.
Measured: At baseline, 1 month, every 4 months during treatment period, and at the end of treatment (up to 5 years).
Brief Pain Inventory - Short Form (BP-SFI) questionnaire
The Brief Pain Inventory (BPI) questionnaire rapidly assesses the severity of pain and its impact on functioning. This self-report questionnaire includes:
- A body schema
- The maximum pain, lowest pain, usual pain within the last 15 days (Numeric rating scales (NRS) 0 to 10)
- Description of current analgesic treatment,
- An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 [normal] to 10 [no activity]).
Measured: At baseline, 1 month, every 4 months during treatment period, and at the end of treatment (up to 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start7 Oct 2024
- Primary completion15 Oct 2029 (estimated)
- Study completion7 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Cancer, Castration-ResistantStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Eligible patients will be randomly allocated in a 1:1 ratio to either the: * Control arm: ADT + darolutamide. * Experimental arm: ADT + darolutamide + SBRT.
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276465
- Sponsor's protocol ID
- UC-GTG-2306
- Other IDs
- 2023-507482-26-00, 2023
- Acronym
- PEACE8
- Status last verified
- Dec 2024
- First submitted
- 16 Feb 2024
- Last updated
- 20 Dec 2024
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Darolutamide and Stereotactic Body Radiation Therapy in Patients With Castration Resistant Prostate Cancer and Oligometastases on Functional Imaging
- ClinicalTrials.gov ID
- NCT06276465
- Acronym / sponsor ID
- PEACE8 / UC-GTG-2306
- Conditions
- Prostatic Cancer, Castration-Resistant
- Keywords
- Phase 3, International, Multicentric, Randomised, Stereotactic body radiation therapy (SBRT), PET-PSMA, mCRPC, nmCRPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 15 Oct 2029 (estimated)
- Study completion
- 7 Oct 2032 (estimated)
- First posted
- 26 Feb 2024 (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.
In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.
In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.
An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.
The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.
The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide.
Detailed description
PEACE 8 is a phase III open-label, randomised (patients are randomly assigned to treatment), international, multicentre trial, evaluating the benefit of adding SBRT to darolutamide for treating patients with oligometastatic CRPC.
Eligible patients will be randomised into either an experimental group receiving darolutamide + SBRT or a control group receiving darolutamide. In both arms, all patients will receive continuous castration (ADT) during the trial course.
Patients' participation in the trial will not exceed 60 months after randomisation, including a maximum treatment duration of 60 months and follow-up up to 60 months after randomisation.
After signing the consent form, patients will enter the pre-inclusion period (before the start of treatment), during which the investigator will carried out all the tests required to assess their eligibility, including demographic data collection, tumour evaluation, and clinical and biological assessments.
Patients will receive doralutamide until disease progression or unacceptable toxicity for a maximum of 5 years after the start of treatment.
To receive treatment, the patient will need to go to hospital, where, at each visit, the medical team will conduct medical examinations before administering the treatment to assess the patient's general state of health and tolerance to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomly allocated in a 1:1 ratio to either the: * Control arm: ADT + darolutamide. * Experimental arm: ADT + darolutamide + SBRT.
| Arm | Type | Receives |
|---|---|---|
| ADT + darolutamide | Active comparator | Drug: Darolutamide 300 mg, Drug: Androgen deprivation therapyUp to 5 years of treatment |
| ADT + darolutamide + SBRT | Experimental | Drug: Darolutamide 300 mg, Radiation: Stereotactic body radiation therapy, Drug: Androgen deprivation therapyUp to 5 years of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
- Patients aged ≥18 years.
- Patient with histologically confirmed of adenocarcinoma prostate cancer without small cell or pure endocrine features.
- Patient with a history of local treatment with curative intent for localised prostate cancer, including surgery or radiotherapy.
- Patients with castration resistant prostate cancer, defined as either:
Key exclusion criteria (11 listed)
- Patient previously treated for metastatic prostate cancer with a novel hormonal agent (NHA), a CYP17 inhibitor, ketoconazole, chemotherapy, or immunotherapy.
- A history of cancer, other than the prostate cancer under study, within the 3 years prior to study inclusion, excluding cured localised cancer such as non-melanomatous skin cancer and non-muscle invasive bladder cancer.
- Presence of an uncontrolled disease or affection that according to the investigator will hinder compliance with the trial procedures or requires hospitalisation.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) A at screening.
- Patients with known allergy or severe hypersensitivity to the study treatment or any of its excipients.
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 |
|---|---|---|
| Darolutamide 300 mgAlso: Nubeqa2 tablets of 300 mg twice daily (=1200 mg/day) up to 5 years from randomisation | Drug | ADT + darolutamide, ADT + darolutamide + SBRT |
| Stereotactic body radiation therapyAlso: SBRTOver one week,30 Gy in 3 fractions of 10 Gy | Radiation | ADT + darolutamide + SBRT |
| Androgen deprivation therapyAlso: ADTContinuous ADT during the study course. The choice of ADT is left to the discretion of the investigator. | Drug | ADT + darolutamide, ADT + darolutamide + SBRT |
Primary outcome
Radiographic Progression-free survival (rPFS)
Time frame: From randomization to disease progression or death, up to 5 years.
The radiographic Progression-free survival is defined as the time interval between the randomisation and radiographic disease progression with conventional imaging (CT-scan or bone-scan), or death due to any cause, whichever occurs first.
10 secondary outcomes
Time to treatment failure (TTF)
Time frame: From randomization to discontinuation of darolutamide, up to 5 years
Overall survival (OS)
Time frame: From randomization to death from any cause, up to 5 years.
Prostate cancer-specific survival
Time frame: From randomization to death due to prostate cancer, up to 5 years.
Time to PSA progression
Time frame: From randomization to PSA progression, up to 5 years.
Biochemical response rate
Time frame: Throughout study completion, up to 5 years.
Time to next symptomatic skeletal event (SSE)
Time frame: Time from randomization to the first symptomatic skeletal event, up to 5 years.
Time to pain progression
Time frame: Time from randomization to the first occurence of pain progression, up to 5 years.
Safety/tolerance
Time frame: Throughout study completion, up to 5 years.
Functional Assessment of CAncer Therapy - Prostate (FACT-P)
Time frame: At baseline, 1 month, every 4 months during treatment period, and at the end of treatment (up to 5 years).
Brief Pain Inventory - Short Form (BP-SFI) questionnaire
Time frame: At baseline, 1 month, every 4 months during treatment period, and at the end of treatment (up to 5 years).
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 20 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Ronan FLIPPOT, MD principal investigator
Gustave Roussy (Villejuif, France)
David PASQUIER, MD principal investigator
Centre Oscar Lambret, Lille University (Lille, France)
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 Darolutamide 300 mg, Stereotactic body radiation therapy and Androgen deprivation therapy in people with Prostatic Cancer, Castration-Resistant, run by UNICANCER at 4 sites in France.
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 20 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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 France. 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?
Contact Catherine LEGER (0033 7 79 83 23 98, c-leger@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-free survival (rPFS) (time frame: From randomization to disease progression or death, up to 5 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 20 Dec 2024.