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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05367206

Acronym

N6C

Enrollment

280

Registered

2022-05-10

Start date

2022-03-14

Completion date

2027-03-31

Last updated

2022-05-10

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

Conditions

Bulky Neoplasm, Cervical Cancer, Neoadjuvant Chemotherapy

Keywords

cervical cancer, neoadjuvant chemotherapy, bulky neoplasm

Brief 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.

Detailed description

in this phase III tiral , stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis will be randomly assigned to two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life.

Interventions

DRUGAlbumin-Bound Paclitaxel

260mg/m2 q3w \*2 circles

DRUGCarboplatin

AUC 5-6 q3w \* 2 circles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix； 2. 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. 3. age 18 to 70 years； 4. Eastern Cooperative Oncology Group performance status 0 to 2； 5. adequate organ function.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
3-year progression-free survival ratio	up to 3 years	the time from study randomization to 3 years, the ratio for patients without disease progression nor death.

Countries

China

Contacts

Primary ContactJunyun Li, M.D.

LIJUNY@sysucc.org.cn020-87343817

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026