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Could 3 chemo rounds be enough? new trial aims to cut treatment burden

NCT ID NCT05460000

Disease control Sponsor: North Eastern German Society of Gynaecological Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests whether women with advanced ovarian cancer who have had all visible tumor removed can safely receive only 3 cycles of chemotherapy instead of the standard 6, followed by a maintenance drug called niraparib. The goal is to see if the shorter chemo is just as effective at preventing cancer from coming back, while reducing side effects. About 640 participants will be randomly assigned to either 3 or 6 cycles of chemo, both followed by niraparib.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
niraparib (a PARP inhibitor maintenance drug) and chemotherapy (carboplatin + paclitaxel)
What this could lead to
If successful, this could allow some ovarian cancer patients to have fewer chemotherapy cycles without compromising cancer control, reducing side effects.
What could go wrong
This is a Phase 2 trial, so results are preliminary. The shorter chemo might not be as effective, and niraparib has its own side effects like fatigue and nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 640 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 2. Female patient, age ≥ 18 years. 3. FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology) 4. Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively. 5. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score \>83 independent of BRCA status, based on these results. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Patients must be able to take oral medications. 8. Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial. 9. Patients must have normal organ and bone marrow function: 1. Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment 2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 3. Platelet count ≥ 100 x 109/L 4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome 5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2,5 x ULN 6. Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \> 30 mL/min. 10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test result ≤3 days prior to administration of the first dose of study treatment. Patients are considered to be of childbearing potential unless 1 of the following applies: 1. Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or 2. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state. Female patients of reproductive potential must practice highly effective methods (failure rate \< 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of chemotherapy or the last dose of niraparib, whichever occurs later, or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (e.g., calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate. Exclusion Criteria: 1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary. 2. Low-grade ovarian, fallopian tube or peritoneal cancer. 3. Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs. 4. Has known hypersensitivity to platin-containing compounds other than carboplatin. 5. Patients posttransplant, including previous allogeneic bone marrow transplant. 6. Has undergone interval debulking of the tumor. 7. Has received any anti-cancer therapy for ovarian cancer other than primary surgery. 8. Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics). 9. Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor. 10. Bevacizumab is planned to be given together with first line chemotherapy or as maintenance. 11. Clinically significant cardiovascular disease: 1. Cerebrovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment 2. Severe cardiac arrhythmia (recent event or active or uncontrolled) 3. New York Heart Association grade ≥2 congestive heart failure 4. Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy or posterior reversible encephalopathy syndrome 5. History of stroke or transient ischemic attack ≤6 months before start of study treatment 6. Coronary/peripheral artery bypass graft ≤6 months before start of study treatment 7. Deep vein thrombosis or thromboembolic events ≤1 month before start of study treatment 12. History or evidence of brain metastases or spinal cord compression. 13. Known history of MDS or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/AML. 14. Current, clinically relevant bowel obstruction at the time of randomization. 15. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 16. Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria) starting with the screening visit through at least 6 months after the last dose of chemotherapy treatment or through at least 1 month after the last dose of niraparib, whichever occurs later. 17. Participation in another clinical study with an investigational product immediately prior to randomization. Earliest time point for randomization is after the time required for the investigational product to undergo 5 half-lives has passed. 18. Has a known history of Human Immunodeficiency Virus (HIV) infection (known HIV1/HIV2 antibodies positive) or acquired immunodeficiency syndrome (AIDS) related illness. 19. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] has been detected) infection. 20. Has active infection with SARS-CoV-2 (antigen test). 21. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of chemotherapy treatment and while and 28 days after the last dose of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Administration of inactivated vaccines is allowed. 22. Patient has contraindications listed in the most recent SmPC. 23. Patient who might be dependent on the sponsor, CRO, site or the investigator. 22\. In Germany: Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40a S. 1 Nr. 2 AMG.

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Conditions

The condition(s) this trial relates to.

clear cell adenocarcinoma fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian carcinoma ovarian clear cell cancer primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clear cell carcinoma Fallopian tube cancer Ovarian cancer Primary peritoneal carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AO Ordine Mauriziano

    RECRUITING

    Torino, Italy

  • AOU Cagliari

    NOT_YET_RECRUITING

    Monserrato, Italy

  • AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

    RECRUITING

    Torino, Italy

  • ASST Lecco - Ospedale A. Manzoni

    ACTIVE_NOT_RECRUITING

    Lecco, Italy

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy

  • Azienda Ospedaliera Universitaria Pisana

    ACTIVE_NOT_RECRUITING

    Pisa, Italy

  • Azienda USL IRCCS Di Reggio Emilia

    ACTIVE_NOT_RECRUITING

    Reggio Emilia, Italy

  • CIOCC Clara Campal

    RECRUITING

    Madrid, Spain

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

    RECRUITING

    Berlin, 13353, Germany

  • Christliches Klinikum Unna Mitte

    RECRUITING

    Unna, 59423, Germany

  • Cliniques Universitaires St. Luc

    ACTIVE_NOT_RECRUITING

    Brussels, Belgium

  • DRK-Kliniken Berlin-Köpenick

    RECRUITING

    Berlin, 12559, Germany

  • Diakonie Klinikum Schwäbisch Hall

    RECRUITING

    Schwäbisch Hall, Germany

  • Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth

    ACTIVE_NOT_RECRUITING

    Düsseldorf, Germany

  • General University Hospital in Prague

    RECRUITING

    Prague, Czechia

  • H. Althaia Manresa

    ACTIVE_NOT_RECRUITING

    Manresa, Spain

  • H.U. Virgen de la Macarena

    RECRUITING

    Seville, Spain

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    RECRUITING

    Wiesbaden, 65199, Germany

  • Hospital General Universitario Dr. Balmis

    RECRUITING

    Alicante, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital La Fe

    ACTIVE_NOT_RECRUITING

    Valencia, Spain

  • Hospital Universitario Lucus Augusti

    ACTIVE_NOT_RECRUITING

    Lugo, Spain

  • Hospital Universitario Sant Joan de Reus

    RECRUITING

    Tarragona, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Spain

  • Hospital Virgen de las Nieves

    RECRUITING

    Granada, Spain

  • IRCCS Istituto nazionale dei Tumori

    RECRUITING

    Milan, Italy

  • Istituto Oncologico Veneto (IOV)

    RECRUITING

    Padova, Italy

  • Jessa ziekenhuis

    RECRUITING

    Hasselt, Belgium

  • Klinikum Dortmund - Klinikum der Universität Witten Herdecke

    ACTIVE_NOT_RECRUITING

    Dortmund, Germany

  • Klinikum Dritter Orden

    NOT_YET_RECRUITING

    München, Germany

  • Klinikum Lippe

    RECRUITING

    Detmold, Germany

  • Klinikum Mittelbaden Baden-Baden Bühl

    NOT_YET_RECRUITING

    Baden-Baden, Germany

  • Policlinico St. Orsola Malpighi

    RECRUITING

    Bologna, Italy

  • SLK-Kliniken Heilbronn

    NOT_YET_RECRUITING

    Heilbronn, Germany

  • UZ Gent

    ACTIVE_NOT_RECRUITING

    Ghent, Belgium

  • UZ Leuven

    ACTIVE_NOT_RECRUITING

    Leuven, Belgium

  • Uniklinikum Bonn

    RECRUITING

    Bonn, Germany

  • University Hospital Bulovka

    ACTIVE_NOT_RECRUITING

    Prague, Czechia

  • University Hospital Ostrava

    RECRUITING

    Ostrava, Czechia

  • Universitätsklinik Göttingen

    ACTIVE_NOT_RECRUITING

    Göttingen, Germany

  • Universitätsklinik Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • Universitätsklinik der Johannes-Gutenberg Universität Mainz

    ACTIVE_NOT_RECRUITING

    Mainz, 55131, Germany

  • Universitätsklinikum Aachen

    RECRUITING

    Aachen, 52074, Germany

  • Universitätsklinikum Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Freiburg

    ACTIVE_NOT_RECRUITING

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    ACTIVE_NOT_RECRUITING

    Hamburg, Germany

  • Universitätsklinikum Köln

    NOT_YET_RECRUITING

    Cologne, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, Germany

  • ZAHO Bonn Onkologische Praxis

    ACTIVE_NOT_RECRUITING

    Bonn, 53115, Germany

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