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

Phase 4

Recruiting

• Conditions: Gynecological Tumor
• Interventions: Drug: Aprepitant Injection

• Registration Number: NCT06007586
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Study Start: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-02-10
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

1. Age 20-75 years old;
2. ECOG PS：0～2;
3. She was diagnosed as gynecological malignant tumor and was to receive TC chemotherapy;
4. Carboplatin AUC 5～6mg/ml/min；
5. Basically normal organ function (normal bilirubin level circumference, normal range of creatinine, ALT< 2 times the upper limit of normal, AST< 2 times the upper normal value)

Exclusion Criteria

1. Patients with previous history of chemotherapy, radiotherapy or targeted therapy;
2. Malignant tumors with brain metastases;
3. History of gastrointestinal malignancy;
4. History of brain tumor;
5. Previous gastrointestinal surgery history, such as segmental resection, (partial) gastrectomy, except intestinal polyp resection and appendectomy;
6. (incomplete) intestinal obstruction;
7. Vestibular dysfunction;
8. Massive abdominal accumulation liquid (except for those who have undergone puncture drainage);
9. Opioid concomitant drug users;
10. Diabetic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two antiemetic groups	Aprepitant Injection	Placebo 130mg iv d1 30min d1 before chemotherapy (IV time \> 2min);Ondansetron 8mg iv once d1 30min before chemotherapy; Dexamethasone 12mg iv once d1 before chemotherapy 30min, dexamethasone 8mg po qd d2 \~ 4.
Three antiemetic group	Aprepitant Injection	Aprepitant injection 130mg iv d1 30min d1 before chemotherapy (push-back time \> 2min);Ondansetron 8mg iv once d1 30min before chemotherapy;Dexamethasone 12mg iv once d1 30min before chemotherapy, 8mg po qd d2-4.

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rate in the delayed period	24 hours to 7days	CR is defined as a patient who does not need rescue antiemesis treatment, no vomiting or retching.

Trial Locations

Locations (2)

Sichuan Cancer Hospital; 🇨🇳 Chengdu, China

Dengfeng Wang; 🇨🇳 Chengdu, Sichua, China