NCT04055038

Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)

Randomized Phase II/III Trial to Assess the Efficacy of Platinum-based Chemotherapy vs Standard Non-platinum Therapy in Patients With Platinum-resistant Recurrent Ovarian Cancer (ROC)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II/III randomized controlled trial to evaluate efficacy of platinum-based chemotherapy vs conventionally prescribed non-platinum monochemotherapy in patients with platinum-resistant ovarian cancer

Detailed description

Recurrent ovarian cancer (ROC) is usually subdivided to platinum-sensitive (platinum-free interval \[PFI\] ≥6 mo.) and platinum-resistant ovarian cancer \[PROC\] (PFI \<6 mo.) subtypes. Prognosis for the latter group is dismal and current guidelines recommend treating these patients with non-platinum based chemotherapy. However, the evidence behind this is quite unconvincing and according to recent data patients with non-platinum refractory platinum-resistant ovarian cancer could derive benefit from platinum rechallenge. This trial is designed for head-to-head comparison of platinum and non-platinum therapy efficacy in treatment of platinum-resistant ovarian cancer.

Conditions

• Ovarian Cancer
• Ovarian Neoplasms
• Serous Adenocarcinoma
• BRCA1 Mutation
• BRCA2 Mutation
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Platinum-Based Drug	Reintroduction of platinum-based chemotherapy
DRUG	Conventional chemotherapy	Conventional chemotherapy

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2019-08-13
• Last updated: 2019-08-13

Locations

1 site across 1 country: Russia