GOG-3068 HIPEC (Hyperthermic Ovarian Cancer Treatment) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find out if giving heated chemotherapy into the belly, a procedure known as heated intraperitoneal chemotherapy (HIPEC), can improve treatment results for patients with ovarian cancer.
¿Cuál es la Condición que se está estudiando?
Stage III and IV Ovarian Cancer
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Are diagnosed with stages III-IV ovarian cancer
- Have not received previous treatment for ovarian cancer with the exception of the first 3-4 cycles of platinum-based neoadjuvant chemotherapy
Para obtener más información sobre quién puede participar en este estudio, comuníquese con el equipo del estudio al 919-684-3780.
Grupo etario
Adultos
¿Qué Implica?
Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) a 1 de 2 grupos:
- One group of participants will receive neoadjuvant chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin. They will then undergo surgery, and then receive HIPEC at the time of surgery.
- The other group will receive neoadjuvant chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin. They will then undergo surgery followed by standard postoperative chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin.
Participants in both groups will then receive maintenance therapy with niraparib for up to 3 years.
Detalles del Estudio
Título Completo
A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy
(HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Homologous Recombinant Deficient (HRD+) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial)
Investigador Principal
Leah McNally, MD, MHS
Especialista en oncología ginecológica
Número de Protocolo
IRB:
PRO00114078
NCT:
NCT05659381
Fase
Phase III
ClinicalTrials.gov
Ver en ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
Participate
Call 919-684-3780