Paclitaxel and Cisplatin for Treating High-Risk Gestational Trophoblastic Tumors
A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
This study is testing a new combination of chemotherapy drugs, paclitaxel and cisplatin, to see if it can help women with high-risk gestational trophoblastic tumors feel better and have fewer side effects than traditional treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | N/A to 60 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT02639650 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of a chemotherapy regimen combining paclitaxel and cisplatin as the first-line treatment for high-risk gestational trophoblastic tumors (GTN). The study focuses on women with a WHO risk score of 7 or higher, aiming to improve treatment outcomes and reduce severe side effects associated with traditional therapies. By utilizing a multicenter randomized controlled design, the trial seeks to provide robust data on the efficacy of this novel approach in managing GTN. Participants will undergo chemotherapy and be monitored for both treatment response and adverse effects.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese women aged 60 or younger with a confirmed diagnosis of high-risk gestational trophoblastic neoplasia and a WHO risk score between 7 and 13.
Not a fit: Patients with unconfirmed GTN diagnoses or those with specific types of trophoblastic tumors like placental-site trophoblastic tumor or epithelioid trophoblastic tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for women with high-risk gestational trophoblastic tumors.
How similar studies have performed: While the combination of paclitaxel and cisplatin has shown promise in other cancer treatments, this specific application for high-risk GTN is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases * World Health Organization(WHO) risk score ≥7, and less than 13 * Age≤60 years; female, Chinese women * Initial treatment is chemotherapy * Performance status: Karnofsky score≥60 * Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal * Provide written informed consent. Exclusion Criteria: * Patients with unconfirmed diagnosis of GTN * Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) * WHO risk score less than 7 * With severe or uncontrolled internal disease, unable to receive chemotherapy * Concurrently participating in other clinical trials * Unable or unwilling to sign informed consents * Unable or unwilling to abide by protocol
Where this trial is running
Hangzhou, Zhejiang
- Weiguo Lv — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Lu Weiguo, Doctor
- Email: lbwg@zju.edu.cn
- Phone: 86-13588819218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.