Phase III Study Comparing Weekly Dose-Dense Chemotherapy to Standard Treatment in Women With Poor Prognosis Ovarian Cancer After Incomplete Surgery

What this Trial Is About

Researchers are evaluating a new chemotherapy dosing approach in women with poor prognostic ovarian cancers who have unfavorable primary chemosensitivity and incomplete debulking surgery. This phase III trial compares a salvage weekly dose-dense chemotherapy regimen to continuing the standard chemotherapy regimen, aiming to confirm if adjusting the dose and schedule improves outcomes. The study is pragmatic and open-label, reflecting routine clinical practice in a real-world patient population. Participants are randomly assigned to one of two groups an experimental arm receiving a intensified chemotherapy schedule with carboplatin and paclitaxel given weekly in 3-week cycles for three cycles, optionally combined with daily subcutaneous GCSF injections or a standard arm continuing the same 3-weekly carboplatin-paclitaxel regimen used during initial treatment, with optional GCSF support. Randomization accounts for factors like bevacizumab use, BRCA mutation status, and KELIM score subgroup. The treatment period focuses on this chemotherapy phase. During the trial, participants will be monitored for surgery outcomes, overall and progression-free survival, tumor response, and adverse events. Assessments include clinical evaluations and imaging based on RECIST criteria, with follow-up extending up to five years for survival analysis. Researchers will also evaluate the impact of additional treatments like PARP inhibitors and bevacizumab on patient outcomes. The total study duration covers treatment and long-term monitoring of efficacy and safety measures.

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