Menu
Recruiting 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

Phase III Interventional Uterine Cervical Neoplasms Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adjuvant chemotherapy.
Who it may be relevant to
Registry conditions: Uterine Cervical Neoplasms, Cervical Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Adjuvant chemotherapy
    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 outcome measures

  • Disease-free survival (DFS) [Time frame: 5 year]
Secondary outcome measures (4)
  • Overall survival （OS） [Time frame: 5 year]
  • Quality of Life Outcomes [Time frame: 5 years]
  • Quality of Life Outcomes of cervical cancer [Time frame: 5 years]
  • Incidence of Toxicity [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital — Wuhan

Identifiers

NCT: NCT04733820 · 2020-S111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗