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Clinical Trials in China / NCT04723875
Active, not recruiting Phase 3

Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline

NCT04723875 · tracked via the Priya Life Science China tracker
Sponsor
Huazhong University of Science and Technology
Phase
Phase 3
Started
2021-01-28
Last updated
2024-11-01

Condition(s) studied

Uterine Cervical NeoplasmsCervical Cancer

Investigational drug(s) / intervention(s)

Paclitaxel or docetaxel + Cisplatin or carboplatin

Paclitaxel or docetaxel + Cisplatin or carboplatin: Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2, 30min + Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.

Study 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 enrolled to receive adjuvant chemotherapy. The primary endpoint was disease-free survival (DFS) rate at 3 year. The secondary endpoints were 5-year DFS, overall survival (OS) and safety.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer. 2. 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. 3. Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma. 4. 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. 5. Age:18-70 years old. 6. 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. 7. Eastern Cooperative Oncology Group score 0-1. 8. Well-compliance and willing to keep in touch. 9. Willing to participate in this study, and sign the informed consent. Exclusion Criteria: 1. Postoperative pathology has high-risk factors(lymph node metastasis, parametrial infiltration or positive surgical margin)or meets Sedlis criteria. 2. Participate in other clinical trials at the same time. 3. 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. 4. Persons without disposing capacity. 5. Drug and/or alcohol abuse. 6. Unable or unwilling to sign informed consents. 7. Not eligible for the study judged by researchers.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei
Qilu Hospital, Shandong University, 107 West Wenhua Road Ji'nan Shandong
Women's Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

More Huazhong University of Science and Technology trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04723875 on ClinicalTrials.gov ↗ ← All trials in China