Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients

November 26, 2025 updated by: Dengfeng Wang, Sichuan Cancer Hospital and Research Institute

A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.

Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Optimal prophylaxis is uncertain. This trial evaluated whether adding the NK1 receptor antagonist aprepitant to standard two-drug prophylaxis (5-HT3 receptor antagonist plus dexamethasone) improves CINV control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of TC in patients with gynecological malignant tumors High-level evidence-based medical evidence for programme-induced CINV. Therefore, different guidelines recommend the best antiemetic regimen as well It's different. This study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The designed Phase III clinical study provides important data and basis for clinical practice and guideline formulation.

In this prospective, multicenter, double-blind, placebo-controlled, crossover phase III trial, patients with gynecologic malignancies scheduled for at least two cycles of TC were randomly assigned to receive aprepitant or placebo with ondansetron and dexamethasone during cycle 1, crossing over to the alternate regimen in cycle 2. The primary endpoint was complete response (CR: no emesis, no significant nausea and no rescue therapy) in the delayed phase (24-168 hours). Secondary endpoints included CR in acute and overall phases, nausea severity, rescue medication use, adverse events, and patient satisfaction.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • Sichuan Cancer Hospital
    • Sichua
      • Chengdu, Sichua, China, 610041
        • Dengfeng Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility criteria: histologically confirmed gynecologic malignancies (including newly diagnosed cases and recurrent cases without chemo- or radiotherapy within the past six months); age 20-75 years; ECOG performance status 0-2; scheduled to receive at least two cycles of paclitaxel (175 mg/m²) plus carboplatin (AUC 5-6) every 3 weeks; and adequate organ function (bilirubin and creatinine within normal range, ALT and AST < 2× upper limit of normal).

Exclusion criteria: included prior chemotherapy, radiotherapy, or targeted therapy for the current recurrence; known brain metastases or history of brain tumors; history of gastrointestinal malignancy or major gastrointestinal surgery (except polypectomy or appendectomy); incomplete bowel obstruction; vestibular dysfunction; massive ascites (unless drained); concomitant opioid use; or diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

patients in group A received the two-drug antiemetic regimen (placebo cycle) during the first cycle followed by the three-drug regimen (aprepitant cycle) during the second cycle.

The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.

The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime
Drug: Aprepitant Injection
Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.
Other Names:
  • dexamethasone
  • ondansetron
Experimental: Group B

patients in group B received the regimens in the reverse order. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime.

The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.
Drug: Aprepitant Injection
Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.
Other Names:
  • dexamethasone
  • ondansetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response (CR) rate in the delayed period
Time Frame: 24 hours to 7days after chemotherapy (each cycle is 21 days)
CR is defined as no emesis, no significant nausea (VAS ≤4, where 0 = none, 10= = most severe), and no use of rescue antiemetics.
24 hours to 7days after chemotherapy (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR rates in the acute phase (0-24 hours) and overall phase (0-7 days).
Time Frame: acute phase: within 24 hours after chemotherapy (each cycle is 21 days); overall phase: within 7 days after chemotherapy (each cycle is 21 days).
CR rates in the acute phase (0-24 hours) and overall phase (0-7 days).
acute phase: within 24 hours after chemotherapy (each cycle is 21 days); overall phase: within 7 days after chemotherapy (each cycle is 21 days).
the use of rescue antiemetic
Time Frame: within 7 days after chemotherapy (each cycle is 21 days).
the use of rescue antiemetic (0-7 days)
within 7 days after chemotherapy (each cycle is 21 days).
patient satisfaction
Time Frame: On day 7 and 14 of each cycle (each cycle is 21 days).
patient satisfaction assessed with a 7-point Likert-type scale (1=Very dissatisfied; 2=dissatisfied; 3=Relatively dissatisfied; 4=quite satisfied; 5=somewhat satisfied; 6=Satisfied; 7=Very satisfied)
On day 7 and 14 of each cycle (each cycle is 21 days).
AEs
Time Frame: within 7 days after chemotherapy (each cycle is 21 days).
incidence of adverse events
within 7 days after chemotherapy (each cycle is 21 days).
severity of nausea
Time Frame: within 7 days after chemotherapy (each cycle is 21 days).
severity of nausea (VAS: 0 = none, 10 = most severe)
within 7 days after chemotherapy (each cycle is 21 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Cancer Hospital and Research Institute

Collaborators

Qilu Pharmaceutical Co., Ltd.
the Norman Bethune's "Research Wing Promotion"-Supporting Research Projects
Peking Union Medical College Hospital Talent Cultivation Program
Medical High Level Talents Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2024

Primary Completion (Actual)

June 20, 2025

Study Completion (Actual)

July 4, 2025

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINV202306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe