Neoadjuvant chemotherapy followed by surgery for locally advanced cervical cancer
Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
This study is testing if giving chemotherapy before surgery helps women with locally advanced cervical cancer respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT03963882 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of neoadjuvant chemotherapy in patients with locally advanced cervical cancer. Sixty participants will receive two cycles of chemotherapy using paclitaxel and cisplatin, followed by imaging assessments to determine their response. Those who show an objective response will undergo radical hysterectomy, while others will discuss alternative treatment options. The study aims to assess both imaging and pathological responses to improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 with confirmed locally advanced cervical cancer (FIGO stage IB2 to IIB).
Not a fit: Patients with distant metastasis or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment effectiveness and outcomes for patients with locally advanced cervical cancer.
How similar studies have performed: Other studies have shown promising results with neoadjuvant chemotherapy in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix * FIGO stage IB2 to IIB * Type II or III radical hysterectomy or trachelectomy * Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 * Aged 18 years to 45 years * Well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy * Signed an approved informed consents Exclusion Criteria: * Not satisfying any of the inclusion criteria
Where this trial is running
Beijing, Beijing
- Lei Li — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Lei Li, M.D. — Peking Union Medical College Hospital
- Study coordinator: Lei Li, M.D.
- Email: lileigh@163.com
- Phone: +8613911988831
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.