None listed
Conditions
Interventions
Drug, Procedure/Surgery : 1) Experimental Group
Liposomal doxorubicin plus carboplatin and bevacizumab chemotherapy after secondary cytoreductive surgery
- Liposomal doxorubicin, 30mg/m2, IV, q4w, 6
Sponsors
Koera University Guro Hospital
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 after end of last platinum- containing therapy, - Progressed during PARP inhibitor maintenance or treatment free interval biologic agent (TFIb) < 3 months - Women aged = 19 years - Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned 1. A positive AGO-score and/or iMODEL+PET/CT 2. Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative. - Patients who have given their signed and written informed consent and their consent to data transmission and -processing.
Exclusion criteria
Exclusion criteria: - Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy - Patients with non-epithelial tumors as well as borderline tumors - More than one prior chemotherapy - Patients who are ineligible for pegylated liposomal doxorubicin or carboplatin - 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 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(Progression-free survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete resection as prognostic factor;Complication rate associated with surgery until definitive hospital discharge ;Predictive and prognostic value of CA-125, duration of PARPi maintenance, BRCA status;OS(Overall Survival);QoL(Quality of Life) | — |
Countries
Korea, Republic of
Contacts
Public ContactMinseo Kim
KGOG(Korea Gynecologic Oncology Group)
Outcome results
None listed