Neoadjuvant chemotherapy followed by chemoradiation for advanced cervical cancer
Department of Radiation, Sun Yat-sen University
PHASE3 · Sun Yat-sen University · NCT05367206
This study is testing if giving a special chemotherapy before standard radiation treatment can help people with advanced cervical cancer live longer and feel better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdone) |
| Trial ID | NCT05367206 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the efficacy and safety of neoadjuvant chemotherapy using albumin-bound paclitaxel and carboplatin, followed by chemoradiation therapy for patients with stage IIIC cervical cancer characterized by bulky tumors. Participants will be randomly assigned to receive either the combination of neoadjuvant chemotherapy and standard chemoradiation or standard chemoradiation alone. The primary endpoint is progression-free survival over three years, while secondary endpoints include response rate, locoregional control, overall survival, safety, and quality of life assessments.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 70 with pathologically confirmed stage IIIC cervical cancer and bulky tumors.
Not a fit: Patients with other types of tumors or those not at initial diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with advanced cervical cancer.
How similar studies have performed: Previous 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: 1. pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix； 2. FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \>4 cm in greatest dimension and/or lymph node \>2 cm in short axis at initial diagnosis. 3. age 18 to 70 years； 4. Eastern Cooperative Oncology Group performance status 0 to 2； 5. adequate organ function. Exclusion Criteria: 1\. not at initial diagnosis; 2. with other kind of tumor. \-
Where this trial is running
Guangzhou, Guangdone
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdone, China (RECRUITING)
Study contacts
- Study coordinator: Junyun Li, M.D.
- Email: LIJUNY@sysucc.org.cn
- Phone: 020-87343817
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.
Conditions: Cervical Cancer, Neoadjuvant Chemotherapy, Bulky Neoplasm, cervical cancer, neoadjuvant chemotherapy, bulky neoplasm