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

NCT04723875Active, Not RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Huazhong University of Science and Technology

Enrollment

306

Start Date

2021-01-28

Completion Date

2026-01-31

Study Type

INTERVENTIONAL

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

Interventions

Paclitaxel or docetaxel + Cisplatin or carboplatin

Conditions

Uterine Cervical NeoplasmsCervical Cancer

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: 3 year

Secondary Outcomes

Overall survival (OS)

OS is defined as the time from the date of randomization until death of any cause.

Time frame: 3 year

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.

Time frame: 5 years

Incidence of Toxicity

The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0.

Time frame: 2 years

Locations

Tongji Hospital, Wuhan, China

Qilu Hospital, Shandong University, 107 West Wenhua Road, Ji'nan, China

Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China