Tests extra chemotherapy after surgery for locally advanced cervical cancer
Tests extra chemotherapy after surgery in women with locally advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 70 with cervical cancer, stage IB3 to IIB, with a tumor larger than 4 cm (1.6 in). They have chemotherapy before surgery and then surgery. It tests chemotherapy after surgery against follow-up visits only.
- Age
- 18 to 70 years
- Sex
- Women only
- Disease stage
- Cervical cancer, FIGO 2018 stage IB3 to IIB, with a tumor diameter over 4 cm (1.6 in) before treatment. The cancer is confirmed under the microscope as squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
- Earlier treatment
- 2 to 3 cycles of chemotherapy before surgery, then a radical hysterectomy with pelvic lymph node removal. The cancer area is sealed before the vagina is cut, and no uterine manipulator is used.
Main reasons for not taking part
- After surgery: lymph node spread, spread beside the uterus, or cancer at the surgical margin
- After surgery: risk factors that meet the Sedlis standard of the NCCN guideline
- Chemotherapy before surgery differs from the chemotherapy planned after surgery
- Taking part in another clinical trial
- Severe diseases of other important organs or systems, or drug or alcohol abuse
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT04733820, who can take part
Where in China
- Tongji HospitalWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Huazhong University of Science and Technology
- Trial code
- NCT04733820
- Record updated
- 2 February 2021
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Drug and/or alcohol abuse; 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; Severe diseases of other important systems and organs; Postoperative risk factors meet the Sedlis standard of the NCCN guideline; Participate in other clinical trials; Persons without disposing capacity; Unable or unwilling to sign informed consents; Not eligible for the study judged by researchers.