Surgery and Niraparib for recurrent ovarian cancer

A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer

This study is testing whether surgery followed by chemotherapy and a drug called Niraparib can help people with recurrent ovarian cancer do better than just chemotherapy alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Gynecologic Oncology Group (Government)
• Drugs / interventions: bevacizumab, chemotherapy
• Locations: 5 sites (Shanghai, Shanghai Municipality and 4 other locations)
• Trial ID: NCT03983226 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with platinum-sensitive secondary recurrent ovarian cancer who meet specific treatment history criteria.

Not a fit: Patients with primary ovarian cancer or those who have not experienced a recurrence may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with recurrent ovarian cancer.

How similar studies have performed: Other studies have shown promising results with similar surgical and maintenance therapy approaches in ovarian cancer, indicating potential for success.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality and 4 other locations

• 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.

Conditions Ovarian Cancer Recurrent; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; reurrent Ovarian Cancer; Secondary Cytoreductive Surgery; Chemotherapy; Niraparib maintenance