Surgery and Niraparib for recurrent ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, open-label, multicenter trial evaluates the effectiveness of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer. Participants are divided into three cohorts based on their prior treatment history with PARP inhibitors and secondary cytoreductive surgery. The study aims to compare outcomes between those receiving surgery and chemotherapy versus those receiving chemotherapy alone followed by Niraparib maintenance. The trial seeks to determine the best approach for improving patient outcomes in this challenging cancer setting.

Why it matters

Who can join: the full rules

Inclusion 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 Co-PI reach consensus if extensive lesions or carcinomatosis.
* 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.

Exclusion Criteria:

* 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.

Where it's running

• Fudan University Shanghai Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, China Not yet recruiting
• Zhejiang Cancer Hospital
  Hangzhou, China Not yet recruiting
• Fudan University
  Shanghai, China Not yet recruiting
• Shanghai Jiao Tong University
  Shanghai, China Not yet recruiting

Study contacts

• Principal investigator: Tingyan Shi, M.D., Ph.D. — Shanghai Gynecologic Oncology Group
• Study coordinator: Rong Jiang, M.D.
• Email: jiang.rong@zs-hospital.sh.cn
• Phone: +862164041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.