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New treatment option for Ovarian Cancer Recurrent
Official title Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
ClinicalTrials.gov ID: NCT03983226
What this study is testing
What is carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...?
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... is an investigational medicine, being studied as a potential treatment for ovarian cancer recurrent.
Also referred to as third-line therapy.
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
- This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence.
- 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 to 75, women only
You may be able to join if
- Age ≥18 years to ≤ 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)
- Cohort 1 and Cohort 3: No prior use of PARP inhibitor.
You likely can't join if
- Patients with borderline tumors as well as non-epithelial tumors.
- Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.
- Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.
- Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).
- Third relapse or more.
- Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian...
See the full eligibility criteria
- Age ≥18 years to ≤ 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)
- Cohort 1 and Cohort 3: No prior use of PARP inhibitor.
- Cohort 2: Prior use of PARP inhibitor.
- Cohort 3: No prior use of PARP inhibitor.
- Secondary cytoreductive surgery (SCR) when first recurrence
- Cohort 1 and Cohort 2: Never received SCR
- Cohort 2: Never received SCR
- Cohort 3: Received SCR
- Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography/computed tomography (PET/CT). PI and...
- It can be included if single lesion outside the peritoneal cavity can be resected.
- No more than 3 disease lesions by central-reviewed PET/CT imaging if the participated center has never participated in any surgical trials on ovarian cancer before.
- Patients who have given their signed and written informed consent and their consent.
- Patients with borderline tumors as well as non-epithelial tumors.
- Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.
- Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.
- Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).
- Third relapse or more.
- Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
- Progression during chemotherapy or recurrence within 6 months after second-line platinum-based therapy
- Any contradiction not allowing surgery and/or chemotherapy and/or or Niraparib
- Accompanied by hypoxia serious chronic obstructive pulmonary disease
- Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
- Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
- Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
- Uncontrolled diabetes
- Uncontrolled epilepsy need long-term antiepileptic treatment.
- Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents.
- ≥3 grade anemia, neutropenia or thrombocytopenia due to chemotherapy, and lasted for more than 4 weeks
- Patients with a known hypersensitivity to Niraparib or any of the excipients of the product.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Guangzhou, China
- Hangzhou, China
- Shanghai, China
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 - 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Guangzhou, China; Hangzhou, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.