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

Phase 3

Active, not recruiting

• Conditions: Uterine Cervical Neoplasms; Cervical Cancer
• Interventions: Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin

• Registration Number: NCT04723875
• Lead Sponsor: Huazhong University of Science and Technology

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Study Start: 2021-01-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 306

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant chemotherapy group	Paclitaxel or docetaxel + Cisplatin or carboplatin	Participant will receive 3 cycles of adjuvant chemotherapy if having any of the following factors；participant will receive 6 cycles of adjuvant chemotherapy if having ≥2 of the following factors. Risk factors: (1) Deep cervical invasion（≥ 2/3）；（2）Differentiation grade 2-3；（3）Lymphatic vascular space infiltration；（4）Adenocarcinoma or adenosquamous carcinoma；（5）Tumor size ≥ 2cm

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	3 year	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival （OS）	3 year	OS is defined as the time from the date of randomization until death of any cause.
5-year DFS/OS	5 years	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.
Incidence of Toxicity	2 years	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.

Trial Locations

Locations (3)

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

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

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China