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Active, Not Recruiting

NCT Number: NCT04723875

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uterine Cervical Neoplasms Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer.
  • 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.
  • Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma.
  • 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.
  • Age：18-70 years old.
  • 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.
  • Eastern Cooperative Oncology Group score 0-1.
  • Well-compliance and willing to keep in touch.
  • Willing to participate in this study, and sign the informed consent.

Exclusion criteria

  • Postoperative pathology has high-risk factors（lymph node metastasis, parametrial infiltration or positive surgical margin）or meets Sedlis criteria.
  • Participate in other clinical trials at the same time.
  • 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.
  • Persons without disposing capacity.
  • Drug and/or alcohol abuse.
  • Unable or unwilling to sign informed consents.
  • Not eligible for the study judged by researchers.

Treatment and study plan

Paclitaxel or docetaxel + Cisplatin or carboplatin

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.

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 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 outcomes

  1. Overall survival （OS）

    Time frame: 3 year

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

  2. 5-year DFS/OS

    Time frame: 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.

  3. Incidence of Toxicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2021
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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