NCT03180177

Brief Summary

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-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
263

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2018

Typical duration for phase_3

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

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

June 6, 2017

Last Update Submit

January 22, 2018

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Keywords

Hyperthermic Intraperitoneal ChemotherapyNeoadjuvant ChemotherapyInterval Debulking SurgeryAdvanced-Stage Epithelial Ovarian CancerPostoperative Chemotherapy

Outcome Measures

Primary Outcomes (3)

  • PR/SD rate

    calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms

    Through study completion, an average of 1 year

  • Percentage of optimal debulking surgery

    evaluate the percentage of optimal debulk (residual disease \< 1cm) after interval debulking surgery between study arms

    Through study completion, an average of 1 year

  • Disease-free survival rate

    assess disease free survival rate during 3 years in both study arms

    3 years

Secondary Outcomes (4)

  • Overall survival rate

    3 years

  • Risk factors for morbidity and mortality

    Through study completion, an average of 1 year

  • Quality of life

    3 years

  • Quality of life for ovarian cancer

    3 years

Study Arms (2)

Experimental group

EXPERIMENTAL

1. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks 3. Interval debulking surgery 4. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 5. 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks

Procedure: Hyperthermic Intraperitoneal ChemotherapyProcedure: Interval debulking surgeryDrug: neoadjuvant chemotherapyDrug: adjuvant chemotherapy

Control group

ACTIVE COMPARATOR

1. 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks 2. Interval debulking surgery 3. 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks

Procedure: Interval debulking surgeryDrug: neoadjuvant chemotherapyDrug: adjuvant chemotherapy

Interventions

Hyperthermic Intraperitoneal ChemotherapyPROCEDURE

HIPEC is performed as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m\^2, 43°C, 90min.

Also known as: HIPEC
Experimental group
Interval debulking surgeryPROCEDURE

Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.

Also known as: IDS
Control groupExperimental group
neoadjuvant 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 laparoscopic exploration 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: NACT
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 and IV)
  • Fagotti score by laparoscopic exploration \>= 6
  • After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD).
  • Residual tumor \< 1cm after completion of interval debulking 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
  • After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor.
  • 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 (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal ChemotherapyNeoadjuvant TherapyChemotherapy, 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, Induced

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

Xianzi Yang, M.D

CONTACT

0086-188-9853-41677097359@qq.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President of Affiliated Tumor Hospital of Guangzhou Medical University

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

March 1, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)