NCT03373058

Brief Summary

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.

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
310

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2019

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

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

December 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

December 4, 2017

Last Update Submit

November 4, 2019

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Keywords

Hyperthermic Intraperitoneal ChemotherapyAdvanced-Stage Epithelial Ovarian CancerCytoreductive surgeryPostoperative Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Median recurrence-free survival

    assess median recurrence-free survival during 3 years in both study arms

    3 years

Secondary Outcomes (4)

  • Median overall survival

    3 years

  • Median progression-free survival

    3 years

  • Risk factors for morbidity and mortality

    30 days; 3 years

  • Quality of life for ovarian cancer

    3 years

Study Arms (2)

Experimental group

EXPERIMENTAL

1. Cytoreductive surgery 2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 3. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour(Docetaxel 75 mg/m\^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks.

Procedure: Hyperthermic Intraperitoneal ChemotherapyProcedure: cytoreductive surgeryDrug: adjuvant chemotherapy

Control group

ACTIVE COMPARATOR

1. Cytoreductive surgery 2. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour(Docetaxel 75 mg/m\^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks.

Procedure: cytoreductive surgeryDrug: adjuvant chemotherapy

Interventions

Hyperthermic Intraperitoneal ChemotherapyPROCEDURE

HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2, respectively, 43°C, 90min.

Also known as: HIPEC
Experimental group
cytoreductive surgeryPROCEDURE

Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.

Also known as: CRS
Control groupExperimental group
adjuvant chemotherapyDRUG

Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.

Also known as: ACT
Control groupExperimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
  • Fagotti score by laparoscopic exploration \< 6
  • Residual tumor \< 1cm after completion of cytoreductive surgery
  • \< Age \< 70 year old
  • Expected survival \> 3 months
  • Performance status: ECOG 0-1
  • Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
  • Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
  • Voluntary participation after getting written informed consent.

You may not qualify if:

  • Fagotti score by laparoscopic exploration \>= 6
  • Suboptimal debulking (residual tumor \> 1cm)
  • Extensive adhesion in peritoneal cavity
  • Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
  • Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
  • Receiving other chemotherapy, radiotherapy or immunotherapy
  • Patients who are unsuitable candidates by doctor's decision
  • Without given written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guanzhou, Guangdong, 510235, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Hubei General Hospital

Wuhan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal ChemotherapyCytoreduction Surgical ProceduresChemotherapy, Adjuvant

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 TherapyTherapeuticsDrug TherapyHyperthermia, InducedSurgical Procedures, Operative

Study Officials

  • Shuzhong Cui, M.D

    Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    STUDY DIRECTOR

  • Zhongqiu Lin, M.D

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Shuzhong Cui, M.D

CONTACT

0086-138-0251-3800cuishuzhong@126.com

Xian-Zi Yang, M.D

CONTACT

0086-188-9853-41677097359@qq.com

Study Design

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

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 14, 2017

Study Start

October 15, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2023

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

CN(7)