Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

October 18, 2022 updated by: Qinglei Gao, Tongji Hospital
This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation or can not tolerate surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. The informed consent form must be provided before any procedure of the trial, and the informed consent form shall be filed in the research center;
  2. Female patients aged between 18 and 75 years old;
  3. Patients received open surgery, laparoscopic surgery, or coarse needle aspiration biopsy and confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer). FIGO stage III-IV;
  4. BRCA1/2 gene mutation or HRD was confirmed by tissue or blood samples detected by the testing institution designated by the research center;
  5. Blood and tissue samples can be obtained before, during, and after treatment, and the subjects agree to submit the blood and tissue samples to the central laboratory for the expanded research purposes of the trial, including but not limited to: I. possible gene-related research. II. Possible tumor markers related studies;
  6. There is at least one lesion that can be measured by CT / MRI;

  7. The professional gynecological oncologists appointed by each center should judge the patients who can not achieve R0 tumor reduction or can not tolerate surgery,

    The criteria for failure to achieve R0 tumor reduction include but are not limited to:

    i. Fagotti score ≥ 8 [2];

    II. When the laparoscopic evaluation method is difficult to implement, the upper abdominal CT Score ≥ 3 can be used [3].

    The criteria for intolerance to surgery can be considered as follows:

    III. advanced age: age ≥ 80;

    IV. body mass index: BMI ≥ 40.0;

    v. A variety of chronic diseases;

    Vi. malnutrition or hypoproteinemia;

    VII. Moderate to massive ascites;

    VIII. Newly diagnosed venous thromboembolism;

    IX. physical status: ECOG > 2.

  8. The expected survival time was more than 12 weeks;
  9. The ECOG score was 0-2;

  10. Good organ function, including:

    i. Bone marrow function: neutrophil count ≥ 1500 / μ L; platelet ≥ 100000 / μ L; hemoglobin ≥ 10g / dl

    II. Liver function: total bilirubin ≤ 1.5 times of the upper limit of normal value or direct bilirubin ≤ 1.0 times of the upper limit of normal value; AST and alt ≤ 2.5 times of the upper limit of normal value; when liver metastasis exists, it must be ≤ 5 times of the upper limit of normal value

    III. renal function: serum creatinine ≤ 1.5 times the upper limit of normal value, or creatinine clearance rate ≥ 60ml / min (calculated according to Cockcroft Gault formula);

  11. For women with fertility potential, if blood test or urine pregnancy test is negative within one week before enrollment, effective contraceptive measures must be taken, such as physical barrier contraceptive method (condom) or complete abstinence. Oral, injectable or implantable hormonal contraceptives are not allowed. Or women without reproductive potential, defined as:

    i. Natural menopause and menopause for more than 1 year;

    II. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy);

    III. serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels were within the menopausal criteria of the research center laboratory.

  12. Understand the trial process and have the ability to comply with the trial protocol for the trial duration, including any treatment, examination, inspection, follow-up, and questionnaire required for the completion of the experiment;
  13. The patients were willing to complete the questionnaire survey of quality of life during the trial treatment and follow-up, and agreed that the results of the questionnaire survey could be used in clinical research;
  14. The toxicity of any previous chemotherapy has returned to ≤ CTCAE 1 or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤ CTCAE grade 2.

Exclusion Criteria:

-

The enrolled patients should not contain any of the following conditions:

  1. Personnel involved in the formulation or implementation of the research plan;
  2. Other clinical drug experiments participated in by using other experimental research drugs at the same time as the study;
  3. At the same time of this study, other neoadjuvant therapies for cancer should be used, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine treatment, and other experimental therapies;
  4. Those who are known to be allergic to niraparib or active or inactive components of drugs with a similar chemical structure to niraparib;
  5. Inability to swallow oral drugs and any gastrointestinal diseases that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption;
  6. Have received any anti-cancer treatment for ovarian cancer;
  7. Have been treated with known or possible PARP inhibitors in the past;
  8. Symptomatic or uncontrolled brain metastases requiring simultaneous treatment, including but not limited to surgery, radiation and / or corticosteroids, or clinical manifestations of spinal cord compression;
  9. Major surgery was performed within 3 weeks before the start of the study or did not recover after the operation;
  10. The subjects had other malignant diseases in the past 3 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ.
  11. The patient had a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
  12. Patients with serious and uncontrollable diseases or the general situation of the subjects judged by the researchers to be unsuitable for joining the study, including but not limited to: active viral infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; severe cardiovascular disease, uncontrollable ventricular arrhythmia, myocardial infarction in the last three months; uncontrollable epileptic grand mal seizure, no control Stable spinal cord compression, superior vena cava syndrome or other mental disorders that affect patients' informed consent; hypertension beyond drug control; immune deficiency (except splenectomy) or other diseases that researchers believe may expose patients to high-risk toxicity; and;
  13. Any medical history or existing clinical evidence indicates that there may be confusion of study results, interference with patients' compliance with the trial protocol throughout the study treatment period, or not in the best interests of patients;
  14. The patient received platelet or red blood cell transfusion within four weeks before the start of treatment of the study drug;
  15. Patients who are pregnant or breastfeeding, or who plan to become pregnant during the study treatment.
  16. Unsolved clinical toxicity (≥ grade 2, except alopecia, neuralgia, lymphopenia, and depigmentation of skin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Niraparib group
Niraparib was used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose (e.g. 200 mg is 2 capsules of 100 mg) should be strictly controlled according to the experimental design.
Drug: Niraparib
Niraparib was used as 100mg capsules once a day since cycle 1 / day 1. The daily dose (e.g. 200 mg is 2 capsules of 100 mg) should be strictly controlled according to the experimental design. Patients should take medicine regularly every day under the guidance of doctors (the best in the morning). The patient must swallow all the capsules completely and do not chew the capsules. You may drink water or eat when taking medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) After Neoadjuvant treatment
Time Frame: 3-month
Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.
3-month
R0 resection rate
Time Frame: 3-month
the percentage of patients received R0 resection after Niraparib neoadjuvant treatment.
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 3-year
PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
3-year
Disease Control Rate
Time Frame: 3-month
Disease control rate is defined as the proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1 and CA125 according to GCIC guidelines
3-month
Complete pathologic response rate
Time Frame: 3-month
Complete pathologic response rate is measured according to Miller-Panye system.
3-month
Overall survival (OS)
Time Frame: 5-year
Overall survival. OS is defined as the time from the study enrollment to death due to any cause.
5-year
Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)
Time Frame: 5 years
To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Ovarian Cancer questionnaire (score range from 0 to 160. Higher scores represent better quality of life.
5 years
Patient report outcome, EQ-VAS
Time Frame: 3 years
life quality assessment. EQ-VAS, EuroQol-visual analogue scales. Score range from 0 [worse outcome] to 10 [better outcome]).
3 years
Rate of treatment interruption and termination
Time Frame: 5 years
The rate of treatment interruption and termination caused by patients' intolerance of treatment side effects and other reasons;
5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 5 years
To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in patients with stage III, all stage IV ovarian cancer.
5 years
Overall Response Rate (ORR) during niraparib maintain treatment
Time Frame: 1 year

Overall Response Rate according to RECIST1.1 during niraparib maintain treatment.

ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Sun Yat-sen University
Qilu Hospital of Shandong University
Hubei Cancer Hospital
Hunan Cancer Hospital
Obstetrics and Gynecology Hospital of Zhejiang University
Anhui Provincial Cancer Hospital
Jilin Provincial Tumor Hospital
Guangdong Provincial People's Hospital
Renmin Hospital of Wuhan University
First Affiliated Hospital of Suzhou Medical College

Investigators

  • Principal Investigator: Qinglei Gao, MD. PhD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-TJ-OVNN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Contact Prof. Gao for primary data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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