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| Name | Class |
|---|---|
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
| Chong Kun Dang Pharmaceutical Corp. | INDUSTRY |
| Yonsei University | OTHER |
| KGOG: Korean Gynaelogical Onology Group, Korea |
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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.
The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| secondary cytoreductive surgery followed by chemotherapy | Experimental | surgery arm |
|
| chemotherapy | Active Comparator | no surgery arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| secondary cytoreductive surgery | Procedure | Maximum effort cytoreductive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | interval between date of randomization and the date of second relapse/progression or death, whatever occurs first | Up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from date of randomisation until death | Up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to first subsequent anticancer therapy |
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 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
Patients who have given their signed and written informed consent and their consent to data transmission and -processing.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun-Woong Cho, MD. PhD. | Contact | 82-2-2626-3228 | limpcho82@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyun-Woong Cho, MD. PhD. | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39164041 | Derived | Cho HW, Kim HS, Park JY, Lee YY, Lim MC, Lee SJ, Min KJ, Eoh KJ, Lee KB, Kim MK, Song JY, Shim SH, Ji YI, Song YJ, Chang SJ, Kim MK, Abe A, Kobayashi Y, Kajiyama H, Shimada M, Okamoto A, Ng JS, Lee JY. A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on a PARP inhibitor as first-line maintenance therapy: the SOCCER-P study (KGOG 3067/JGOG 3036/APGOT-OV11). Int J Gynecol Cancer. 2024 Nov 4;34(11):1809-1812. doi: 10.1136/ijgc-2024-005838. |
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| UNKNOWN |
| Japanese Gynecologic Oncology Group | OTHER |
| Asia-Pacific Gynecologic Oncology Trials Group | OTHER |
A randomized superiority trial (Surgery versus No Surgery)
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| chemotherapy | Drug | six cycles of platinum-based chemotherapy +/- bevacizumab |
|
|
From date of randomization until the date of first recurrent anticancer therapy
| Up to 1 year |
| Time to second subsequent anticancer therapy | From date of randomization until the date of secondary recurrent anticancer therapy | Up to 2 year |
| Quality of life | EORTC QLQ-C30,OV28, and EQ-5D-5L | baseline, 6 month and 1year after randomization |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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