Status:
RECRUITING
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
Lead Sponsor:
Huazhong University of Science and Technology
Collaborating Sponsors:
Women's Hospital School Of Medicine Zhejiang University
Qilu Hospital of Shandong University
Conditions:
Uterine Cervical Neoplasms
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter \> 4cm before treatment.
- Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
- Age：18-70 years old.
- ECOG status score ≤1;
- 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.
- Well-compliance and willing to keep in touch.
- Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.
Exclusion
- 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.
- Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
- Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
- Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
- Participate in other clinical trials.
- Severe diseases of other important systems and organs.
- Persons without disposing capacity.
- Drug and/or alcohol abuse.
- Unable or unwilling to sign informed consents.
- Not eligible for the study judged by researchers.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT04733820
Start Date
February 1 2021
End Date
February 1 2028
Last Update
February 2 2021
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430000