Ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Conditions
Interventions
To compare progression-free survival (PFS) in patients who had platinum sensitive recurrence during first-line PARP inhibitor maintenance with high probability of complete resection randomized to tumo
Sponsors
Abe Akiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage. Progression-free interval of at least 6 months (180 days) after end of last platinum- containing therapy, Progressed during PARP inhibitor maintenance or treatment free interval biologic agent (TFIb) < 3 months (90 days) Complete resection of the tumor by surgical procedure seems possible (estimated by an experienced surgeon). Patients who have given their signed and written informed consent and their consent to data transmission and -processing.
Exclusion criteria
Exclusion criteria: -Patients with non-epithelial tumors as well as borderline tumors -More than one prior chemotherapy -Patients with second, third, or later recurrence -Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. -Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months (180 days) after end of former first platinum- containing therapy -Only palliative surgery planned -Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible) -Any concomitant disease not allowing surgery and/or chemotherapy -Any medical history indicating excessive peri-operative risk -Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab) -No assessable archival tumor tissue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival PFS2 Rate of complete resection as prognostic factor Complication rate associated with surgery until definitive hospital discharge Exploratory analysis of surgical characteristics and genetic mutation (translational research) Predictive and prognostic value of CA-125, duration of PARPi maintenance, BRCA status | — |
Countries
Japan, South korea
Contacts
Public ContactAkiko Abe
Cancer Institute Hospital, JFCR
Outcome results
None listed