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SALVOVAR trial: A pragmatic randomized phase III trial to assess the utility of adjusting chemotherapy dose & dosing schedule with the SALVage weekly dose-dense regimen in patients with poor prognostic OVARian cancers based on the tumor unfavorable primary chemosensitivity and incomplete debulking surgery.
EU CTIS ID: 2023-508260-30-01
What this study is testing
To demonstrate the superiority in terms of efficacy of a densification of the chemotherapy with the salvage weekly dose-dense carboplatin-paclitaxel regimen (experimental arm) compared to the continuation of the standard 3-weekly carboplatin-paclitaxel (control arm), 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. The efficacy is defined with 2 co-primary endpoints: Percentage of patients operated with late complete debulking surgery after receiving 3 cycles of randomized chemotherapy Overall survival.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
- 10. Patients willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- 2. Adult patient aged ≥ 18 years old
- 3. Advanced stage III or IV disease
- 4. Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel regimen in first-line setting, and characterized by: o Unfavorable standardized KELIMTM score < 1.0 calculated with the KELIM academic tool and available for free on internet site (https://www.biomarker-kinetics.org/CA-125-neo) (poor primary chemosensitivity) o Not amenable to complete interval debulking surgery (incomplete interval debulking surgery attempt, or disease not operated at all because considered not amenable to complete surgery by surgeon) GINECO-OV130b/ENGOT-ov78– SALVOVAR – Protocol - Version 1.0 – 14/DEC/2023 (From FORM 113-04: Protocol – Application date: 30/SEP/2022) Page 8 on 108 Of note, a pre-screening inclusion before the start of neo-adjuvant chemotherapy is encouraged as a way of prospectively assessing the CA-125 longitudinal kinetics and surgery evaluation, and subsequently selecting the patients for the randomization sequence
- 5. ECOG performance status 0 or 1 (see appendix 2)
You likely can't join if
- 1. Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor. Contraindication to the drugs assessed in the SALVOVAR trial (carboplatin, paclitaxel, GCSF)
- 2. Previous treatment with bevacizumab during initial standard neo-adjuvant chemotherapy
- 3. Has primary platinum-refractory disease, defined as disease that has progressed during the neo-adjuvant chemotherapy
- 4. Patients with concomitant cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- 5. Treatment with other investigational agents in clinical trials.
- 6. Clinically significant 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: • Unstable angina. GINECO-OV130b/ENGOT-ov78– SALVOVAR – Protocol - Version 1.0 – 14/DEC/2023 (From FORM 113-04: Protocol – Application date: 30/SEP/2022) Page 9 on 108 • Myocardial infarction within 6 months of first dose. • Uncontrolled and/or severe concomitant diseases (uncontrolled hypertension, ≥ Grade 3 (per CTCAE v5.0) arrhythmia, heart failure, cirrhosis). • Active infectious disease requiring IV therapy (bacteria, viruses) within 2 weeks of first dose. • Gastric-outlet obstruction. • Small bowel obstruction (SBO) defined as computed tomography (CT) scan showing: Dilated loops of small bowel ≤12 weeks of study entry, symptomatic ascites/effusions requiring paracentesis or thoracentesis ≤30 days of study entry.
See the full eligibility criteria
Who can join
- 1. Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
- 10. Patients willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- 2. Adult patient aged ≥ 18 years old
- 3. Advanced stage III or IV disease
- 4. Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel regimen in first-line setting, and characterized by: o Unfavorable standardized KELIMTM score < 1.0 calculated with the KELIM academic tool and available for free on internet site (https://www.biomarker-kinetics.org/CA-125-neo) (poor primary chemosensitivity) o Not amenable to complete interval debulking surgery (incomplete interval debulking surgery attempt, or disease not operated at all because considered not amenable to complete surgery by surgeon) GINECO-OV130b/ENGOT-ov78– SALVOVAR – Protocol - Version 1.0 – 14/DEC/2023 (From FORM 113-04: Protocol – Application date: 30/SEP/2022) Page 8 on 108 Of note, a pre-screening inclusion before the start of neo-adjuvant chemotherapy is encouraged as a way of prospectively assessing the CA-125 longitudinal kinetics and surgery evaluation, and subsequently selecting the patients for the randomization sequence
- 5. ECOG performance status 0 or 1 (see appendix 2)
- 6. Adequate organ and bone marrow function for weekly-dense chemotherapy: red blood cells (baseline Hemoglobin ≥8 g/dL without red blood cell transfusion within 3 weeks before the blood work), white blood cells (Absolute neutrophil count (ANC) ≥1500 cells/mm3) and platelets (Platelet count ≥100,000/mm3),
- 7. Adequate renal and liver functions o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases o Total bilirubin ≤1.5 × ULN (patients with Gilbert’s are eligible if total bilirubin ≤3 × ULN) o Albumin ≥3 g/dL o Creatinine clearance ≥40 mL/min/1.73 m2 (measured or estimated, ideally with CKD-EPI formula on https://www.kidney.org/professionals/kdoqi/gfr_calculator)
- 8. Patients who gave its written informed consent to participate to the study
- 9. Patients affiliated to a social insurance regime
What rules you out
- 1. Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor. Contraindication to the drugs assessed in the SALVOVAR trial (carboplatin, paclitaxel, GCSF)
- 2. Previous treatment with bevacizumab during initial standard neo-adjuvant chemotherapy
- 3. Has primary platinum-refractory disease, defined as disease that has progressed during the neo-adjuvant chemotherapy
- 4. Patients with concomitant cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- 5. Treatment with other investigational agents in clinical trials.
- 6. Clinically significant 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: • Unstable angina. GINECO-OV130b/ENGOT-ov78– SALVOVAR – Protocol - Version 1.0 – 14/DEC/2023 (From FORM 113-04: Protocol – Application date: 30/SEP/2022) Page 9 on 108 • Myocardial infarction within 6 months of first dose. • Uncontrolled and/or severe concomitant diseases (uncontrolled hypertension, ≥ Grade 3 (per CTCAE v5.0) arrhythmia, heart failure, cirrhosis). • Active infectious disease requiring IV therapy (bacteria, viruses) within 2 weeks of first dose. • Gastric-outlet obstruction. • Small bowel obstruction (SBO) defined as computed tomography (CT) scan showing: Dilated loops of small bowel ≤12 weeks of study entry, symptomatic ascites/effusions requiring paracentesis or thoracentesis ≤30 days of study entry.
- 7. Known psychiatric disorder that would interfere with trial compliance.
- 8. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.