NCT01519869

Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma

Neoadjuvant Platinum-based Chemotherapy in Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma Trial Protocol

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Rachel Miller · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable survival, decreased morbidity, and increased quality of life in patients with International Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or fallopian tube cancer when compared to historical controls and to evaluate the hypothesis that cancer induced inflammation is a predictor of poor prognosis and response to therapy in this group of ovarian cancer patients.

Conditions

• Primary Peritoneal Carcinoma
• Ovarian Carcinoma
• Fallopian Tube Carcinoma

Interventions

Type	Name	Description
DRUG	neoadjuvant chemotherapy	platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy

Timeline

• Start date: 2012-03-01
• Primary completion: 2019-10-11
• Completion: 2019-10-11
• First posted: 2012-01-27
• Last updated: 2020-12-14
• Results posted: 2020-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study