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

Cervical Cancer Clinical Trial

Official title:

Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline：A Prospective Multicenter Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723875
• Other study ID #: 2020-S113
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2021
• Source: Huazhong University of Science and Technology
• Contact: Ding Ma, M.D., PhD
• Phone: 0086-27-83662681
• Email: dma[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (7)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	First Affiliated Hospital of Chongqing Medical University, Hunan Cancer Hospital, Obstetrics & Gynecology Hospital of Fudan University, Qilu Hospital of Shandong University, The Third Xiangya Hospital of Central South University, Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.	3 year
Secondary	Overall survival (OS)	OS is defined as the time from the date of randomization until death of any cause.	3 year
Secondary	5-year DFS/OS	DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first. OS is defined as the time from the date of randomization until death of any cause.	5 years