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NCT Number: NCT05367206

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

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Key information

Conditions

Cervical Cancer Bulky Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoadjuvant Chemotherapy Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdone, 510000, China

Location status: Recruiting

Location contact

Junyun Li, M.D.

CONTACT

[email protected]

020-87343817 ext. 86

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • not at initial diagnosis; 2. with other kind of tumor.

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Treatment and study plan

Albumin-bound paclitaxel

Drug

260mg/m2 q3w *2 circles

carboplatin

Drug

AUC 5-6 q3w * 2 circles

Primary outcomes

  1. 3-year progression-free survival ratio

    Time frame: up to 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Junyun Li, M.D.

CONTACT

[email protected]

020-87343817 ext. 86

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Department of Radiation, Sun Yat-sen University

Acronym: N6C

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
May 10, 2022
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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