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

NCT ID: NCT04723875

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2026-01-31

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.

Conditions

Uterine Cervical Neoplasms; Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant chemotherapy group

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

Group Type: EXPERIMENTAL

Paclitaxel or docetaxel + Cisplatin or carboplatin

Intervention Type: DRUG

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.

Control group

The participants receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Ding Ma

Director of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ding Ma, M.D., PhD

Role: STUDY_CHAIR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Qilu Hospital, Shandong University, 107 West Wenhua Road

Ji'nan, Shandong, China

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2020-S113

Identifier Type: -

Identifier Source: org_study_id