Back to resultsNeoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial (N6C)
Primary Purpose
Cervical Cancer, Neoadjuvant Chemotherapy, Bulky Neoplasm
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Albumin-Bound Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, neoadjuvant chemotherapy, bulky neoplasm
Eligibility Criteria
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.
Exclusion Criteria:
1. not at initial diagnosis; 2. with other kind of tumor.
-
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NAC plus RCT
RCT
Arm Description
two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation
standard chemoradiation with weekly cispatin plus pelvic radiation
Outcomes
Primary Outcome Measures
3-year progression-free survival ratio
the time from study randomization to 3 years, the ratio for patients without disease progression nor death.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05367206
Brief Title
Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial
Acronym
N6C
Official Title
Department of Radiation, Sun Yat-sen University
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Neoadjuvant Chemotherapy, Bulky Neoplasm
Keywords
cervical cancer, neoadjuvant chemotherapy, bulky neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAC plus RCT
Arm Type
Experimental
Arm Description
two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation
Arm Title
RCT
Arm Type
No Intervention
Arm Description
standard chemoradiation with weekly cispatin plus pelvic radiation
Intervention Type
Drug
Intervention Name(s)
Albumin-Bound Paclitaxel
Intervention Description
260mg/m2 q3w *2 circles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 5-6 q3w * 2 circles
Primary Outcome Measure Information:
Title
3-year progression-free survival ratio
Description
the time from study randomization to 3 years, the ratio for patients without disease progression nor death.
Time Frame
up to 3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Exclusion Criteria:
1. not at initial diagnosis; 2. with other kind of tumor.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junyun Li, M.D.
Phone
020-87343817
Ext
86
Email
LIJUNY@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdone
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junyun Li, M.D.
Phone
020-87343817
Ext
86
Email
LIJUNY@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial
We'll reach out to this number within 24 hrs