Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

Ovarian Cancer Clinical Trial

— SOCCER-P  

Official title:

A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704621
• Other study ID #: KGOG3067
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: December 28, 2028

Study information

• Verified date: March 2024
• Source: Korea University Guro Hospital
• Contact: Hyun-Woong Cho, MD. PhD.
• Phone: 82-2-2626-3228
• Email: limpcho82[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.

Description:

The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 28, 2028
• Est. primary completion date: December 28, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• Women aged = 18 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 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:

• Patients with non-epithelial tumors as well as borderline tumors.

• Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy

• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• secondary cytoreductive surgery
Maximum effort cytoreductive surgery

Drug:
• chemotherapy
six cycles of bevacizumab [10 mg/kg, days 1 and 15] plus carboplatin [AUC 5, day 1] plus pegylated liposomal doxorubicin [30 mg/m2, day 1] every 4 weeks, followed by maintenance bevacizumab [15 mg/kg every 3 weeks]

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Boryung Pharmaceutical Co., Ltd, Chong Kun Dang Pharmaceutical Corp., Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day post-operative complications	MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications	From the operation until after 30 days
Other	Time to first subsequent anticancer therapy	From date of randomization until the date of first recurrent anticancer therapy	Up to 1 year
Other	Time to second subsequent anticancer therapy	From date of randomization until the date of secondary recurrent anticancer therapy	Up to 2 year
Primary	progression-free survival	interval between date of randomization and the date of second relapse/progression or death, whatever occurs first	Up to 2 year
Secondary	Overall survival	from date of randomisation until death	Up to 2 year