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Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

NCT03371693 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-05-29

No results posted yet for this study

Summary

A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.

Conditions

  • Ovarian Cancer
  • Ovary Neoplasm
  • Ovarian Neoplasms
  • Epithelial Ovarian Cancer
  • Ovarian Cancer, Epithelial
  • Hyperthermic Intraperitoneal Chemotherapy(HIPEC)

Interventions

DEVICE

HIPEC

Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.

DEVICE

CRS

cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.

DEVICE

IVCT

platinum-based intravenous chemotherapy

Sponsors & Collaborators

  • Zhongnan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2022-12-30
Completion
2023-03-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371693 on ClinicalTrials.gov