A Phase 3 interventional study of Carboplatin and Paclitaxel in Ovarian Cancer, sponsored by ARCAGY/ GINECO GROUP. Recruiting at 76 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by ARCAGY/ GINECO GROUP · Phase 3, Interventional, and Treatment
SALVOVAR will be a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the standard regimen.
SALVOVAR is a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the same standard regimen as given during neo-adjuvant period. The randomization will be stratified on the main clinical prognostic factors assumed to impact the efficacy of the assessed arms and the overall survival:
The trial will be pragmatic, as it aims at confirming the superiority of the adjusted chemotherapy compared to the continuation of the standard chemotherapy in routine clinical practice, in a population of ovarian cancer patients close to the real-life clinical activity with few selection criteria.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 250 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →ARCAGY/ GINECO GROUP is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Treated with 3 to 4 cycles of standard 3-weekly carboplatin-paclitaxel regimen in setting, and characterized by:
Adequate renal and liver functions
Non-inclusion Criteria:
uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation, including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles +/- combined with daily sub-cutaneous administrations of GCSF 30 MUI days 3 to 5, \& 10 to 12, \& 17 to 19 (at investigator discretion, as per standard of care).
Drug: Carboplatin · Drug: Paclitaxel
Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy +/- combined with peg-GCSF or GCSF daily sub-cutaneous administrations, at investigator discretion, as per standard of care.
Drug: Carboplatin · Drug: Paclitaxel
Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy
Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy
Percentage of patients operated with late complete debulking surgery
To demonstrate the superiority in terms of efficacy of a densification of the chemotherapy with the salvage weekly dose-dense carboplatin-paclitaxel regimen compared to the continuation of the standard 3-weekly carboplatin-paclitaxel, in ovarian cancer patients found to have a poor prognostic disease (characterized by a poor chemosensitivity, with an unfavorable KELIMTM score \< 1.0, and a disease not amenable to complete interval debulking surgery) after 3 cycles of standard neo-adjuvant chemotherapy.
Time frame: From the date of randomization until patients operated with late complete debulking surgery, assessed up 100 days
Overall survival (OS)
To demonstrate the superiority in terms of efficacy of a densification of the chemotherapy with the salvage weekly dose-dense carboplatin-paclitaxel regimen compared to the continuation of the standard 3-weekly carboplatin-paclitaxel, in ovarian cancer patients found to have a poor prognostic disease (characterized by a poor chemosensitivity, with an unfavorable KELIMTM score \< 1.0, and a disease not amenable to complete interval debulking surgery) after 3 cycles of standard neo-adjuvant chemotherapy.
Time frame: From the date of randomization until death due to any cause, assessed up to 5 years
Percentage of patients operated with late complete debulking surgery, regardless of the number of chemotherapy cycles received
To compare the efficacy, in term of percentage of patients operated with late complete debulking surgery, between the salvage weekly dose-dense regimen and the standard regimen, regardless of the number of chemotherapy cycles received.
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
Overall response rate according to RECIST V1.1 in the whole population
To compare the efficacy of the salvage weekly dose-dense regimen with those of the standard regimen in terms of: * Radiological response after 3 cycles of treatment, based on the best radiological response using RECIST criteria * Progression-free survival
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
Progression-free survival in the whole population
To compare the efficacy of the salvage weekly dose-dense regimen with those of the standard regimen in terms of: • Radiological response after 3 cycles of treatment, based on the best radiological response using RECIST criteria
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
Percentage of patients treated with a subsequent maintenance treatment with a PARP inhibitor (%) in the whole population
To assess the impact of the adjustment to the salvage weekly dose-dense regimen on the rate of subsequent prescription of PARP inhibitors (since these drugs are indicated in patients with complete or partial response to platinum-based chemotherapy) in terms of survival.
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
Progression-free survival and overall survival in these patients compared to those not treated with PARP inhibitor
To assess the impact of the adjustment to the salvage weekly dose-dense regimen on the rate of subsequent prescription of PARP inhibitors (since these drugs are indicated in patients with complete or partial response to platinum-based chemotherapy) in terms of survival.
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes In the population of patients treated with bevacizumab: - Overall response rate according to RECIST V1.1
To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
Adverse events graded according to the NCI Common Terminology Criteria Adverse Event Version 5.0
To compare the safety profiles of the salvage weekly dose-dense chemotherapy arm with those of the standard 3-weekly carboplatin-paclitaxel with/without bevacizumab, based on the observed adverse-events
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
To assess the impact of adding bevacizumab to chemotherapy on the efficacy outcomes In the population of patients treated with bevacizumab: - Progression-free survival & overall survival according to RECIST V1.1
To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
To assess the impact of adding bevacizumab to chemotherapy on the efficacy outcomes In the population of patients treated with bevacizumab: - Percentage of patients operated with a late complete debulking surgery (%)
To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes
Time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years
Quality of life questionnaires
To compare the quality of life and patient-reported outcomes of the salvage chemotherapy arm with those of the standard regimen
Time frame: from date of randomization through study completion, an average of 3 years
Perceptions of the patient-doctor relationship in patients offered bevacizumab/debulking surgery/PARPi
Measure of patient-doctor relationship: The Patient-Doctor Relationship Questionnaire measures patient perceptions of the patient-doctor relationship. Participants rate the level of helpfulness, time, trust, understanding, dedication, agreement, availability, contentment, and accessibility of their healthcare provider. All nine items are rated on a five-point Likert scale from 1 (Not at all appropriate) to 5 (totally appropriate). Mean scores are calculated, and higher scores indicate a better perceived doctor-patient relationship.
Time frame: From 4-8 weeks after a decision on bevacizumab (approx. at randomization date) through end of follow-up (2-3 years after inclusion, depending on debulking surgery)
Satisfaction with decision-making process in patients offered bevacizumab/debulking surgery/PARPi
Measure of satisfaction with care: One self-generated item developed on the basis of the literature will ask patients in general how they would rate the care they received for their ovarian cancer treatment during the past three months, using a five-point scale from 1 (poor) to 5 (excellent). A higher score reflects a higher satisfaction with their care.
Time frame: From 4-8 weeks after a decision on bevacizumab (approx. at randomization date) through end of follow-up (2-3 years after inclusion, depending on debulking surgery)
Satisfaction with decision-making process in patients offered bevacizumab/debulking surgery/PARPi
Measure of decision satisfaction: The Satisfaction with Decision scale measures a patient's level of satisfaction with healthcare decisions. It consists of six statements to which respondents are asked to indicate their level of agreement using a five-point scale, from 1 (strongly disagree) to 5 (strongly agree). Total scores are summed, with higher scores indicating greater decisional satisfaction.
Time frame: From 4-8 weeks after a decision on bevacizumab (approx. at randomization date) through end of follow-up (2-3 years after inclusion, depending on debulking surgery)
Emotional wellbeing following the decision-making process in patients offered bevacizumab/debulking surgery/PARPi
To determine the impact of the decision-making process on emotional wellbeing in the short- and medium-term, among patients who have participated in decision-making regarding bevacizumab as a chemosensitizer, late debulking surgery in the case of favorable response to chemotherapy, or PARP inhibitors and/or bevacizumab as maintenance treatment. Measure of emotional wellbeing: Six self-generated items will be used to measure the concept of eudaimonic or hedonic wellbeing. A 10-point scale from 1 (not at all) to 10 (very much so) will gauge perceptions of feeling hopeful, peaceful, grateful, comforted, connected, and content over the past week, presented as single-word descriptors. Mean scores will be calculated for each subscale, and a mean across all items will be derived to reflect overall emotional wellbeing. Higher scores indicate higher levels of emotional wellbeing.
Time frame: From 4-8 weeks after a decision on bevacizumab (approx. at randomization date) through end of follow-up (2-3 years after inclusion, depending on debulking surgery)
Treatment beliefs in patients offered bevacizumab/PARPi
Measure of treatment beliefs: For patients prescribed PARP inhibitors and/or bevacizumab, four items will be presented to measure treatment beliefs in relation to these treatments. These items are adapted from a Treatment Beliefs Questionnaire originally developed for patients with low back pain, which has been adapted for the current setting with permission. This self-report scale consists of four items assessing perceptions of credibility, effectiveness, concerns, and individual fit of treatment, which are rated on a five-point scale from (1) strongly disagree to (5) strongly agree. Higher scores for each item indicate more positive beliefs about the treatment (with responses on the 'concerns' item being reverse scored).
Time frame: From 4-8 weeks after a decision on bevacizumab (approx. at randomization date) through end of follow-up (2-3 years after inclusion, depending on debulking surgery)
Self-reported adherence to PARPi in patients offered PARPi
Measure of treatment (PARPi) adherence: For patients prescribed PARP inhibitors, a three-item scale will be used to measure adherence to PARPi and bevacizumab. Patients will be asked about the number of days in which they missed at least one dose of the treatment (answered numerically), the frequency with which they took their medication in the way they were supposed to over the previous 30 days (rated on a 6-point scale from never to always), and their rating of how 'good a job' they did at taking their medication in the way recommended over the previous 30 days (rated on a 6-point scale from very poor to excellent). Responses will be linearly transformed to a 0-100 scale for analyses, with 0 representing the worst adherence and 100 the best. Summary scores will be calculated as the mean of the three items.
Time frame: From 4-8 weeks after a decision on PARPi (approx. at end of chemotherapy) through end of follow-up (2-3 years after inclusion, depending on debulking surgery)
Percentage of patients with BRCA (BReast CAncer) mutation (%)
Number of patients with BRCA mutation involved in homologous recombination (%)
Time frame: from date of randomization through study completion, an average of 5 years
Percentage of patients with BRCA wild-type HRD (Homologous Recombination Deficiency) disease (%)
Number of patients with BRCA wild-type HRD mutation involved in homologous recombination (%)
Time frame: from date of randomization until end of study, for a period of 5 years
Percentage of patients with BRCA wild-type HRP (Homologous Recombination Proficient) disease (%)
Number of patients with BRCA wild-type HRP mutation involved in homologous recombination (%)
Time frame: from date of randomization through study completion, an average of 3 years
Tests/assays used (names, proprietary)
Name of tests/assays used in real-life setting
Time frame: from date of randomization until end of study, through study completion, an average of 3 years
Percentage of tests/assays used (names, proprietary) (%)
Percentage of tests/assays used in real-life setting (%)
Time frame: from date of randomization until end of study, through study completion, an average of 3 years
Incremental cost-utility ratio
To assess the cost-utility evaluations of the experimental treatment (medico-economic evaluation) in the French context Salvage weekly dose-dense regimen vs the standard regimen, as per randomization Addition of bevacizumab to chemotherapy, as per investigator decision Late debulking surgery after chemotherapy in the case of favorable response to chemotherapy, as per investigator decision Maintenance treatment with bevacizumab with/without PARP inhibitor, or surveillance, as per investigator decision
Time frame: from date of randomization until end of study, for a periof of 5 years
Incremental cost-effectiveness ratio
To assess the cost-effectiveness evaluations of the experimental treatment (medico-economic evaluation) in the French context Salvage weekly dose-dense regimen vs the standard 3-weekly regimen, as per randomization Addition of bevacizumab to chemotherapy, as per investigator decision Late debulking surgery after chemotherapy in the case of favorable response to chemotherapy, as per investigator decision Maintenance treatment with bevacizumab with/without PARP inhibitor, or surveillance, as per investigator decision
Time frame: from date of randomization until end of study, for a period of 5 years
Estimate the net financial impact over 5 years
A budget impact analysis (BIA) to estimate the financial impact for French Health Insurance of the generalization in the French context of the strategy based on the experimental treatment.
Time frame: from date of randomization until end of study, for a period of 5 years
Started Jul 2024 (actual). Primary completion is estimated for Jun 2027, 35 months after the start.
Of 52 non-industry phase 3 interventional studies under Ovarian Neoplasms, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 115. This study's planned 35 months is below that.
Counting every sponsor, half of 125 studies reached it within 59 months; a quarter within 37 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Carboplatin · Paclitaxel
ARCAGY/ GINECO GROUP