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

Cervical Cancer Clinical Trial

— N6C  

Official title:

Department of Radiation, Sun Yat-sen University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367206
• Other study ID #: SunYat-sen University
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Junyun Li, M.D.
• Phone: 020-87343817
• Email: LIJUNY[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

-

Related Conditions & MeSH terms

• Cervical Cancer
• Neoadjuvant Chemotherapy
• Uterine Cervical Neoplasms

Intervention

Drug:
• Albumin-Bound Paclitaxel
260mg/m2 q3w *2 circles
• Carboplatin
AUC 5-6 q3w * 2 circles

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdone

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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