Status:
ACTIVE_NOT_RECRUITING
Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline
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 who undergo radical surgery but do not meet criteria of adjuvant therapy according to NCCN guideline are e...
Eligibility Criteria
Inclusion
- Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer.
- The initial treatment was radical hysterectomy + pelvic lymphadenectomy by laparotomy or laparoscopy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
- Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma.
- Assessment of risk factors not meeting Sedlis criteria （NCCN guideline），but having one of following factors ：（1）Deep stromal infiltration（≥2/3 layer）；（2）histopathological differentiation grade G2 \~ G3；（3）Lymph-vascular space invasion ；（4）Adenocarcinoma or adenosquamous cell carcinoma；（5）Tumor size ≥2cm.
- Age：18-70 years old.
- 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.
- Eastern Cooperative Oncology Group score 0-1.
- Well-compliance and willing to keep in touch.
- Willing to participate in this study, and sign the informed consent.
Exclusion
- Postoperative pathology has high-risk factors（lymph node metastasis, parametrial infiltration or positive surgical margin）or meets Sedlis criteria.
- Participate in other clinical trials at the same time.
- Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery.
- 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 :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04723875
Start Date
January 28 2021
End Date
January 31 2026
Last Update
November 1 2024
Active Locations (3)
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1
Tongji Hospital
Wuhan, Hubei, China, 430000
2
Qilu Hospital, Shandong University, 107 West Wenhua Road
Ji'nan, Shandong, China, 250012
3
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310022