NCT04515602

Brief Summary

The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
410

participants targeted

Target at P50-P75 for phase_3

Timeline
20mo left

Started Jan 2021

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
not yet 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 Progress76%
Jan 2021Jan 2028

First Submitted

Initial submission to the registry

August 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

7 years

First QC Date

August 14, 2020

Last Update Submit

August 25, 2020

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time from randomization to the date of death from any cause or date of last contact

    Participants will be followed for at least 5 years after randomization

Secondary Outcomes (8)

  • Progression-free survival

    Participants will be followed for at least 2 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 12 months or death after randomization, whichever came first

  • Quality of life assessments

    Participants will be followed for at least 12 months or death after randomization, whichever came first

  • Accumulating treatment-free survival

    Participants will be followed for at least 5 years or death after randomization, whichever came first

  • +3 more secondary outcomes

Study Arms (4)

Part 1 Arm I (low/medium tumor burden)

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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

Procedure: Primary debulking surgeryDrug: PARPi

Part 1 Arm II (low/medium tumor burden)

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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

Procedure: Neoadjuvant chemotherapyDrug: PARPi

Part 2 Arm I (high tumor burden)

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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

Procedure: Primary debulking surgeryDrug: PARPi

Part 2 Arm II (high tumor burden)

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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

Procedure: Neoadjuvant chemotherapyDrug: PARPi

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
Part 1 Arm I (low/medium tumor burden)Part 2 Arm I (high tumor burden)
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
Part 1 Arm II (low/medium tumor burden)Part 2 Arm II (high tumor burden)
PARPiDRUG

For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.

Part 1 Arm I (low/medium tumor burden)Part 1 Arm II (low/medium tumor burden)Part 2 Arm I (high tumor burden)Part 2 Arm II (high tumor burden)

Eligibility Criteria

Age18 Years+
Sexfemale
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 (diagnosis by biopsy or core needle biopsy\*, laparoscopic biopsy is not recommended). \* If core needle biopsy could not be performed, patients should satisfy the following conditions:
  • the patient has a pelvic mass, and
  • omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis (FIGO IV), and
  • preoperative CA125/CEA ratio \> 25. If CA125/CEA ratio ≤ 25, imaging or endoscopy is obligatory to exclude a primary gastric, colon, or breast carcinoma.
  • cPCI score ≤ 8.
  • Performance status (ECOG 0-2).
  • Good ASA score (1/2).
  • 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.
  • cPCI score \> 8.
  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
  • Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
  • Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
  • For Part 2:
  • Females aged ≥ 18 years, and \< 70 years.
  • Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
  • cPCI score ≥ 10.
  • For FIGO IVB patients, abdominal lesions should be confined to one lobe of liver parenchyma metastasis or splenic metastasis. All extra-abdominal metastases should be resectable, such as inguinal lymph nodes, solitary supraclavicular, retrocrural or paracardial nodes.
  • Good performance status (ECOG 0-1).
  • Good ASA score (1/2).
  • Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Obstetrics & Gynecology Hospital of Fundan University

Shanghai, China

Location

Shanghai First Maternity and Infant Hospital

Shanghai, China

Location

Shanghai Jiao Tong University School of Medicine Xinhua Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian 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 TherapyTherapeutics

Central Study Contacts

Lina Shen, MD

CONTACT

86 21 64041990shen.lina@zs-hospital.sh.cn

Tingyu Luan

CONTACT

86 21 64041990luan.yuting@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 17, 2020

Study Start

January 1, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)