Ovarian Cancer study: Chemotherapy
Official title Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
ClinicalTrials.gov ID: NCT05704621
What this study is testing
What is chemotherapy?
chemotherapy is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Also referred to as no surgery and only chemotherapy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether a second round of cytoreductive surgery improves outcomes for patients whose ovarian cancer progressed while on PARP inhibitor maintenance.
- Who it's for
- Women with relapsed ovarian cancer who have progressed while receiving PARP inhibitor maintenance therapy.
- What's involved
- Participants are randomly assigned to undergo secondary cytoreductive surgery or to continue without surgery, and will have regular follow‑up visits and standard medical tests.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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).
You likely can't join if
- 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 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...
- Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first...
See the full eligibility 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...
- A positive AGO-score or iMODEL+PET/CT
- 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.
- 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 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seoul, South Korea. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.