The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChongqing University Cancer Hospital

About this trial

This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and/or OS with lymph node dissection before CCRT when compared to CCRT.

Eligibility criteria

Qualifiers

Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma

Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm

ECOG score 0~1

Expected survival over 6 months

Disqualifiers

Activity or uncontrol severe infection

Active hepatitis B, Liver cirrhosis, Decompensated liver disease

History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease

Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies

Trial design

Treatments tested in this trial

  • Lymph node dissection
  • Standard chemoradiation±pembrolizumab
  • Chemoradiation± pembrolizumab

Treatment groups

452 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chongqing University Cancer Hospital

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Jiangxi Provincial Cancer Hospital

Collaborator

Anhui Provincial Cancer Hospital

Collaborator

The Second Affiliated Hospital of Harbin Medical University

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

Zhejiang Cancer Hospital

Collaborator

Women's Hospital School Of Medicine Zhejiang University

Collaborator

Qilu Hospital of Shandong University

Collaborator

Fujian Cancer Hospital

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

Cancer Hospital of Guizhou Province

Collaborator

West China Second University Hospital

Collaborator

Tongji Hospital

Collaborator

The Affiliated Ganzhou Hospital of Nanchang University

Collaborator

First Affiliated Hospital of Gannan Medical University

Collaborator

Gansu Provincial Maternal and Child Health Care Hospital

Collaborator

Third Affiliated Hospital of Xinjiang Medical University

Collaborator

Affiliated Cancer Hospital of Shantou University Medical College

Collaborator

Obstetrics & Gynecology Hospital of Fudan University

Collaborator

The Second Affiliated Hospital of Dalian Medical University

Collaborator

Fujian Maternity and Child Health Hospital

Collaborator

Shandong Cancer Hospital and Institute

Collaborator

Sun Yat-Sen University Cancer Center

Collaborator