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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Neoadjuvant Chemotherapy; Bulky Neoplasm; Cervical Cancer

Treatments: Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05367206

SunYat-sen University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

NAC plus RCT

Experimental group

Description:

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

Treatment:

Drug: Albumin-Bound Paclitaxel

Drug: Carboplatin

RCT

No Intervention group

Description:

standard chemoradiation with weekly cispatin plus pelvic radiation