NCT05200260

Brief Summary

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
13mo left

Started Jul 2022

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2022Jun 2027

First Submitted

Initial submission to the registry

January 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 10, 2025

Status Verified

November 1, 2024

Enrollment Period

4.9 years

First QC Date

January 17, 2022

Last Update Submit

February 6, 2025

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Keywords

Ovarian CancerPrimary Debulking SurgeryNeoadjuvant chemotherapyPoly-adenosine Ribose Phosphate Inhbitors (PARPi)Bevacizumab

Outcome Measures

Primary Outcomes (1)

  • 3-year overall survival

    The proportion of patients alive at 3 years after entry into the study

    Participants will be followed for at least 3 years after randomization

Secondary Outcomes (8)

  • Overall survival

    Participants will be followed for at least 3 years after randomization

  • Progression-free survival

    Participants will be followed for at least 3 years after randomization

  • Post-operative complications

    Participants will be followed up to 3 months after randomization

  • Quality of life assessments

    Participants will be followed for at least 3 years after randomization

  • Accumulated treatment-free survival

    Participants will be followed for at least 3 years or death after randomization

  • +3 more secondary outcomes

Study Arms (2)

Upfront cytoreductive surgery with maintenance therapy

EXPERIMENTAL

Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).

Procedure: Primary debulking surgeryDrug: PARP inhibitorDrug: Bevacizumab

Neoadjuvant chemotherapy with maintenance therapy

ACTIVE COMPARATOR

Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).

Procedure: Neoadjuvant chemotherapyDrug: PARP inhibitorDrug: Bevacizumab

Interventions

Primary debulking surgeryPROCEDURE

Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.

Also known as: PDS
Upfront cytoreductive surgery with maintenance therapy
Neoadjuvant chemotherapyPROCEDURE

3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.

Also known as: Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS
Neoadjuvant chemotherapy with maintenance therapy
PARP inhibitorDRUG

For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.

Also known as: Olaparib
Neoadjuvant chemotherapy with maintenance therapyUpfront cytoreductive surgery with maintenance therapy
BevacizumabDRUG

For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.

Neoadjuvant chemotherapy with maintenance therapyUpfront cytoreductive surgery with maintenance therapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females aged ≥ 18 years.
  • Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
  • Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
  • Complete cytoreduction can be achieved based on CT or PET/CT examination
  • Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
  • Performance status (ECOG 0-2)
  • Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
  • white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
  • serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
  • serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
  • Comply with the study protocol and follow-up.
  • Patients who have given their written informed consent.

You may not qualify if:

  • Non-epithelial ovarian malignancies and borderline tumors
  • Low grade ovarian cancer
  • Mucinous ovarian cancer
  • Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
  • Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
  • Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
  • Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The First People's Hospital of Foshan

Foshan, China

RECRUITING

Sun Yet-Sen University Cancer Center

Guangzhou, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China

RECRUITING

Fudan University Cancer Hospital

Shanghai, China

RECRUITING

Obstetrics and Gynecology Hospital of Fundan University

Shanghai, China

RECRUITING

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Neoadjuvant TherapyPoly(ADP-ribose) Polymerase InhibitorsolaparibBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic UsesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Libing Xiang

    Fudan University

    STUDY CHAIR

Central Study Contacts

Libing Xiang

CONTACT

86 21 64041990xiang.libing@zs-hospital.sh.cn

Rong Jiang

CONTACT

86 21 64041990jiang.rong@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 20, 2022

Study Start

July 13, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 10, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(9)