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

Phase 3

Recruiting

• Conditions: Neoadjuvant Chemotherapy; Cervical Cancer; Bulky Neoplasm
• Interventions: Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

• Registration Number: NCT05367206
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2022-03-14
• Status Verified: 2022-05
• Study First Submitted: 2022-05-01
• Study First Submitted QC: 2022-05-09
• Last Update Submitted: 2022-05-09
• Study First Posted: 2022-05-10
• Last Update Posted: 2022-05-10
• Primary Completion: 2024-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC plus RCT	Albumin-Bound Paclitaxel	two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation
NAC plus RCT	Carboplatin	two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdone, China