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NCT Number: NCT04733820

Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.
  • Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
  • Age:18-70 years old.
  • ECOG status score ≤1;
  • 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.
  • Well-compliance and willing to keep in touch.
  • Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.

Exclusion criteria

  • After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
  • Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
  • Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
  • Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
  • Participate in other clinical trials.
  • Severe diseases of other important systems and organs.
  • 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

Adjuvant chemotherapy

Drug

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.

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 5 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: 5 year

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

  2. Quality of Life Outcomes

    Time frame: 5 years

    Patients are asked to complete the questionnaire EORTC QLQ-C30

  3. Quality of Life Outcomes of cervical cancer

    Time frame: 5 years

    Patients are asked to complete the questionnaire EORTC QLQ-CX24

  4. Incidence of Toxicity

    Time frame: 5 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ding Ma, M.D., PhD

CONTACT

[email protected]

0086-27-83662681

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2021

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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