Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regim… (NCT06476184) | Clinical Trial Compass
RecruitingPhase 3
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
France250 participantsStarted 2024-07-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
✓. Adult patient aged ≥ 18 years old
✓. Advanced stage III or IV disease
✓. Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel regimen in first-line setting, and characterized by:
✓. ECOG performance status 0 or 1 (see appendix 2)
✓. 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),
✓. Adequate renal and liver functions
✓. Patients who gave its written informed consent to participate to the study
Exclusion criteria
✕. 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)
✕. Previous treatment with bevacizumab during initial standard neo-adjuvant chemotherapy
✕. Has primary platinum-refractory disease, defined as disease that has progressed during the neo-adjuvant chemotherapy
What they're measuring
1
Percentage of patients operated with late complete debulking surgery
Timeframe: From the date of randomization until patients operated with late complete debulking surgery, assessed up 100 days
2
Overall survival (OS)
Timeframe: From the date of randomization until death due to any cause, assessed up to 5 years
✕. 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
✕. Treatment with other investigational agents in clinical trials.
✕. 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:
✕. Known psychiatric disorder that would interfere with trial compliance.
✕. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial.