N6C: Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05367206

Collaborator

(none)

280

Enrollment

Location

Arms

60.6

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Neoadjuvant Chemotherapy Bulky Neoplasm	Drug: Albumin-Bound Paclitaxel Drug: Carboplatin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Department of Radiation, Sun Yat-sen University

Actual Study Start Date :

Mar 14, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAC plus RCT two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation	Drug: Albumin-Bound Paclitaxel 260mg/m2 q3w 2 circles Drug: Carboplatin* AUC 5-6 q3w * 2 circles
No Intervention: RCT standard chemoradiation with weekly cispatin plus pelvic radiation

Arm

Intervention/Treatment

Experimental: NAC plus RCT

two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation

Drug: Albumin-Bound Paclitaxel

260mg/m2 q3w *2 circles

Drug: Carboplatin

AUC 5-6 q3w * 2 circles

No Intervention: RCT

standard chemoradiation with weekly cispatin plus pelvic radiation

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.