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Ovarian Cancer RecurrentPhase 2NCT03983226

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

A Phase 2 study testing Surgery, carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... and Niraparib in people with Ovarian Cancer Recurrent and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Surgery, carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... and Niraparib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
5 sitesChina
Study dates
18 Oct 2019to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rong Jiang, M.D. contact

+862164041990

jiang.rong@zs-hospital.sh.cn

Yuting Luan, R.N. contact

+862164041990

yutingluan@163.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Yanling Feng

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Wen Gao

    Not yet recruiting

  • Fudan University Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Rong Jiang, MD, +862164041990, jiang.rong@zs-hospital.sh.cn

    Yuting Luan, RN, +862164041990, yutingluan@163.com

    Recruiting

  • Fudan University

    Shanghai

    Wei Jiang

    Not yet recruiting

  • Shanghai Jiao Tong University

    Shanghai

    Wei Bao

    Not yet recruiting

Other trials in China

About this study

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

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. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.

Read the detailed description

This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer.

Being tested
Surgery, carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin..., Niraparib
Keywords
reurrent Ovarian Cancer, Secondary Cytoreductive Surgery, Chemotherapy, Niraparib maintenance
Medical subject headings
Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Also called secondary cytoreduction

    Tumor debulking surgery (surgery in recurrent ovarian disease)

  • carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...Drug

    Also called third-line therapy

    Salvage chemotherapy

  • NiraparibDrug

    Also called maintenance therapy

    Niraparib maintenance therapy

Study groups in NCT03983226
Study groupRoleWhat they receive
SurgeryExperimentalIntervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Receives: Procedure: Surgery; Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...; Drug: Niraparib
No surgeryActive comparatorIntervention: Drug: Platinum-based chemotherapy and Niraparib
Receives: Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...; Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-month disease non-progression rate

    12-month non-progression rate

    Measured: up to 12 months after last patient randomized

Secondary outcomes (5)

  1. Progression-free survival

    from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)

    Measured: Up to 24 months after last patient randomized

  2. Treatment free survival

    It is the area between Kaplan-Meier curves for two time-to-event end points: 1) time to protocol chemotherapy cessation and 2) time to first subsequent anticancer therapy initiation or death, whichever occurred first.

    Measured: Up to 24 months after last patient randomized

  3. Overall survival

    from date of randomization until the date of death from any cause

    Measured: Approximately up to 24 months after last patient randomized

  4. 30-day post-operative complications

    surgical complications grading criteria will be adopted for evaluating the perioperative complications

    Measured: From the operation until after 30 days

  5. Quality of life assessment

    the European Organization for Research and Treatment (EORTC) core quality of life questionnaire (QLQ-C30, version 3.0) The total score (range from 0 to 1,000)

    Measured: baseline; 6 and 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start18 Oct 2019
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized umbrella clinical trial
Masking
None (open label)
Enrolment
167 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03983226
Sponsor's protocol ID
SGOG OV5
Other IDs
SGOG OV-05
Status last verified
Mar 2022
First submitted
5 Jun 2019
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi T, Yin S, Zhu J, Zhang P, Liu J, Zhu Y, Wu S, Chen X, Wang X, Teng Y, Zhu T, Yu A, Zhang Y, Feng Y, Huang H, Bao W, Li Y, Jiang W, Zhang P, Li J, Ai Z, Zhang W, Jia H, Zhang Y, Jiang R, Zhang J, Gao W, Luan Y, Zang R. A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study. J Gynecol Oncol. 2020 May;31(3):e61. doi: 10.3802/jgo.2020.31.e61.

    PubMed 32319233

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgery, carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... and Niraparib in people with Ovarian Cancer Recurrent and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rong Jiang, M.D. (+862164041990, jiang.rong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month disease non-progression rate (time frame: up to 12 months after last patient randomized). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03983226, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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