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

ConditionsCervical CancerNeoadjuvant ChemotherapyBulky Neoplasm
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Albumin-Bound Paclitaxel

    Drug

    260mg/m2 q3w \*2 circles

  • Carboplatin

    Drug

    AUC 5-6 q3w \* 2 circles

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: NAC plus RCTExperimental treatment 2 interventions
Group B: RCTNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

3-year progression-free survival ratio

the time from study randomization to 3 years, the ratio for patients without disease progression nor death.

Time frame
up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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