Status:
COMPLETED
Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients
Lead Sponsor:
Sichuan Cancer Hospital and Research Institute
Collaborating Sponsors:
the Norman Bethune's "Research Wing Promotion"-Supporting Research Projects
Peking Union Medical College Hospital Talent Cultivation Program
Conditions:
Gynecological Tumor
Ovarian Cancer
Eligibility:
FEMALE
20-75 years
Phase:
PHASE3
Brief Summary
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 malignanc...
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 evid...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2025
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT06007586
Start Date
May 31 2024
End Date
July 4 2025
Last Update
December 4 2025
Active Locations (2)
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1
Dengfeng Wang
Chengdu, Sichua, China, 610041
2
Sichuan Cancer Hospital
Chengdu, China