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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Department of Radiation, Sun Yat-sen University

Conditions
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Cervical Cancer, Neoadjuvant Chemotherapy, Bulky Neoplasm

Intervention / Treatment
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* Drug: Albumin-Bound Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC plus RCT<br>two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation | Drug: Albumin-Bound Paclitaxel<br>* 260mg/m2 q3w *2 circles<br>Drug: Carboplatin<br>* AUC 5-6 q3w * 2 circles<br>|
| No Intervention: RCT<br>standard chemoradiation with weekly cispatin plus pelvic radiation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, neoadjuvant chemotherapy, bulky neoplasm