Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial
NCT ID: NCT05367206
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
280 participants
INTERVENTIONAL
2022-03-14
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NAC plus RCT
two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation
Albumin-Bound Paclitaxel
260mg/m2 q3w \*2 circles
Carboplatin
AUC 5-6 q3w \* 2 circles
RCT
standard chemoradiation with weekly cispatin plus pelvic radiation
No interventions assigned to this group
Interventions
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Albumin-Bound Paclitaxel
260mg/m2 q3w \*2 circles
Carboplatin
AUC 5-6 q3w \* 2 circles
Eligibility Criteria
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Inclusion Criteria
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
\-
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Li Junyun
Principal Investigator
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdone, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SunYat-sen University
Identifier Type: -
Identifier Source: org_study_id
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