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

NCT04723875 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-11-01

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Obstetrics & Gynecology Hospital of Fudan University

    collaborator OTHER

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Ding Ma, M.D., PhD · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04723875 on ClinicalTrials.gov