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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05704621
Recruitment Status : Not yet recruiting
First Posted : January 30, 2023
Last Update Posted : March 8, 2023
Sponsor:
Collaborators:
Boryung Pharmaceutical Co., Ltd
Chong Kun Dang Pharmaceutical Corp.
Yonsei University
Information provided by (Responsible Party):
Hyun Woong Cho, Korea University Guro Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug Related Neoplasm/Cancer Procedure: secondary cytoreductive surgery Drug: chemotherapy Phase 2

Detailed Description:
The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : February 28, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: secondary cytoreductive surgery followed by chemotherapy 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]
Active Comparator: chemotherapy 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]


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival [ Time Frame: Up to 2 year ]
    interval between date of randomization and the date of second relapse/progression or death, whatever occurs first


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 2 year ]
    from date of randomisation until death


Other Outcome Measures:
  1. 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications

  2. Time to first subsequent anticancer therapy [ Time Frame: Up to 1 year ]
    From date of randomization until the date of first recurrent anticancer therapy

  3. Time to second subsequent anticancer therapy [ Time Frame: Up to 2 year ]
    From date of randomization until the date of secondary recurrent anticancer therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05704621


Contacts
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Contact: Hyun-Woong Cho, MD. PhD. 82-2-2626-3228 limpcho82@gmail.com

Sponsors and Collaborators
Korea University Guro Hospital
Boryung Pharmaceutical Co., Ltd
Chong Kun Dang Pharmaceutical Corp.
Yonsei University
Investigators
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Principal Investigator: Hyun-Woong Cho, MD. PhD. Korea University Guro Hospital
More Information
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Responsible Party: Hyun Woong Cho, Assistant professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT05704621    
Other Study ID Numbers: KGOG3067
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type