NCT04473339

Brief Summary

A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P25-P50 for phase_3 ovarian-cancer

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_3 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3.1 years

First QC Date

July 12, 2020

Last Update Submit

September 4, 2020

Conditions

Ovarian CancerEpithelial Ovarian CancerOvarian Cancer, EpithelialHyperthermic Intraperitoneal Chemotherapy(HIPEC)Homologous Recombination Repair Gene Mutation

Keywords

Homologous Recombination Repair Gene Mutationhyperthermic intraperitoneal chemotherapyEpithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.

    up to 36 months since diagnosis

Secondary Outcomes (4)

  • Overall Survival

    up to 36 months since histological diagnosis

  • DP9

    the 1 day of histological diagnosis and 9 months after

  • DP12

    the 1 day of histological diagnosis and 12 months after

  • Serious adverse events, SAEs

    surgery and with in 30 days

Study Arms (4)

HRR mt 1

EXPERIMENTAL

Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Procedure: CRS+HIPEC

HRR mt 2

EXPERIMENTAL

Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Procedure: CRS alone

HRR wt 3

EXPERIMENTAL

Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Procedure: CRS+HIPEC

HRR wt 4

EXPERIMENTAL

Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Procedure: CRS alone

Interventions

CRS+HIPECPROCEDURE

Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

HRR mt 1HRR wt 3
CRS alonePROCEDURE

Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

HRR mt 2HRR wt 4

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-75
  • Karnofsky performance status \>50 or World Health Organization performance score \< 2
  • primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
  • preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
  • lesion can be removed completely or residual disease \< 0.5 cm
  • last chemotherapy finished no more than 12 weeks after surgery
  • no hepatic function damage
  • white blood cell count ≥3.5\*10\^9/L; platelet count ≥80\*10\^9/L; Hemoglobin ≥90g/L
  • no contraindication of surgery and anesthesia
  • life expectancy ≥ 3 months
  • informed consent form signed

You may not qualify if:

  • age \< 18 or \>75
  • no history of other cancer
  • platinum allergy
  • distant metastasis
  • used anti-angiogenic drug within 8 weeks
  • possibility of more than two resection of alimentary canal
  • recurrence \< 6 months after primary treatment
  • histologic type: non epithelial origin
  • infection out of control
  • follow-up unable to carry on (geographic or psychic)
  • cardiac insufficiency or respiratory insufficiency
  • has received HIPEC already
  • being in other clinical study
  • pregnancy or lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430070, China

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

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 DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Hongbing Cai, Doctor

CONTACT

+86-27-67812648chb2105@163.com

Zhen Li, Doctor

CONTACT

+86-27-67812648

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Prof.

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 16, 2020

Study Start

August 1, 2020

Primary Completion

August 30, 2023

Study Completion

December 30, 2023

Last Updated

September 9, 2020

Record last verified: 2020-07

Locations

CN(1)