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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042592

Enrollment

Unknown

Registered

2021-01-23

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

Adjuvant chemotherapy group:Platium-based chemotherapy

Control group:No intervention

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment. 2.Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma. 3.Aged 18-70 years. 4.ECOG status score = 3.5*10^9/L, NEU >= 1.5*10^9/L, Platelet >= 80 x 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. 6.Well-compliance and willing to keep in touch. 7.Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.

Exclusion criteria

Exclusion criteria: 1.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. 2.Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens. 3.Postoperative high risk factors: (1)lymph node metastasis, (2) parauterine infiltration, (3) positive surgical margin. 4.Postoperative risk factors meet the Sedlis standard of the NCCN guideline. 5.Participate in other clinical trials. 6.Severe diseases of other important systems and organs. 7.Persons without disposing capacity. 8.Drug and/or alcohol abuse. 9.Not eligible for the study judged by researchers.

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS);	—

Secondary

Measure	Time frame
Overall survival;Quality of Life Outcomes;Incidence of adverse event;	—

Countries

China

Contacts

Public ContactDing Ma

Tongji Hospital, Tongji Medical College, HUST

dma@tjh.tjmu.edu.cn+86 27-83662681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026