NCT04733820 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
| NCT ID | NCT04733820 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 340 participants in total. It began in 2021-02-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04733820 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04733820 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 340 participants.
Is NCT04733820 currently recruiting?
Yes, NCT04733820 is actively recruiting participants. Contact the research team at dma@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT04733820 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT04733820 clinical trial?
NCT04733820 is sponsored by Huazhong University of Science and Technology. The trial plans to enroll 340 participants.