RecruitingPhase 3NCT05367206

Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

Department of Radiation, Sun Yat-sen University


Sponsor

Sun Yat-sen University

Enrollment

280 participants

Start Date

Mar 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix;
  • FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \>4 cm in greatest dimension and/or lymph node \>2 cm in short axis at initial diagnosis.
  • age 18 to 70 years;
  • Eastern Cooperative Oncology Group performance status 0 to 2;
  • adequate organ function.

Exclusion Criteria2

  • \. not at initial diagnosis; 2. with other kind of tumor.
  • \-

Interventions

DRUGAlbumin-Bound Paclitaxel

260mg/m2 q3w \*2 circles

DRUGCarboplatin

AUC 5-6 q3w \* 2 circles


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdone, China

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NCT05367206


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