Adjuvant chemotherapy for locally advanced cervical cancer patients not meeting NCCN guidelines
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
This study is testing if giving extra chemotherapy after surgery helps women with locally advanced cervical cancer who don’t meet standard treatment guidelines live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04733820 on ClinicalTrials.gov |
What this trial studies
This phase 3 randomized controlled trial investigates the efficacy of adjuvant chemotherapy in patients with locally advanced cervical cancer who do not meet the NCCN guidelines for adjuvant treatment after receiving neoadjuvant chemotherapy and surgery. Eligible patients will undergo 2-3 cycles of neoadjuvant chemotherapy followed by surgery, and those who do not qualify for adjuvant therapy will be randomly assigned to receive either adjuvant chemotherapy or just follow-up visits. The primary endpoint is the disease-free survival rate at five years, with secondary endpoints including overall survival, safety, and quality of life assessments.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-70 with FIGO stage IB3, IIA2, or IIB cervical cancer and a tumor size greater than 4 cm.
Not a fit: Patients who have already undergone extensive hysterectomy and pelvic lymph node dissection after neoadjuvant chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with locally advanced cervical cancer who currently lack effective adjuvant therapy.
How similar studies have performed: Other studies have explored adjuvant chemotherapy in cervical cancer, but this specific approach targeting patients not meeting NCCN guidelines is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter \> 4cm before treatment. 2. Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma. 3. Age：18-70 years old. 4. ECOG status score ≤1; 5. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value. 6. Well-compliance and willing to keep in touch. 7. Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol. Exclusion Criteria: 1. After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. 2. Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens. 3. Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin. 4. Postoperative risk factors meet the Sedlis standard of the NCCN guideline. 5. Participate in other clinical trials. 6. Severe diseases of other important systems and organs. 7. Persons without disposing capacity. 8. Drug and/or alcohol abuse. 9. Unable or unwilling to sign informed consents. 10. Not eligible for the study judged by researchers.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Ding Ma, M.D., PhD
- Email: dma@tjh.tjmu.edu.cn
- Phone: 0086-27-83662681
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.