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

August 25, 2025 updated by: Dongling Zou, Chongqing University Cancer Hospital

Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All eligible patients will be equally randomized between the 2 following treatment groups (stratified factors: whether para-aortic lymph nodes were image-positive):

Standard treatment group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy ±pembrolizumab).

Experimental group: open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation±pembrolizumab. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation ±pembrolizumab will be performed postoperatively within 28 days.)

Study Type

Interventional

Enrollment (Estimated)

452

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
        • Principal Investigator:
          • Dongling Zou, M.D.
        • Principal Investigator:
          • Ying Tang, M.D.
        • Sub-Investigator:
          • Misi He, M.M.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
  2. Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
  3. ECOG score 0~1
  4. Expected survival over 6 months
  5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
  6. No surgical contraindication

Exclusion Criteria:

  1. Activity or uncontrol severe infection
  2. Active hepatitis B, Liver cirrhosis, Decompensated liver disease
  3. History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease
  4. 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
  5. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  6. Chronic renal insufficiency or renal failure
  7. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
  8. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
  9. Has had an allogenic tissue/solid organ transplant
  10. A history of pelvic artery embolization
  11. A history of pelvic radiotherapy
  12. A history of partial hysterectomy or radical hysterectomy
  13. A history of immunotherapy or undergoing immunotherapy
  14. A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and/or any excipients
  15. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment group
Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).
Radiation: Standard chemoradiation±pembrolizumab
1. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.
Experimental: Experimental group
Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).
Procedure: Lymph node dissection
Open/minimaly invasive pelvic and para-aortic lymph node dissection
Radiation: Chemoradiation± pembrolizumab
1. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 years
Progression-free survival
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 and 5 years
Overall survival
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Collaborators

Zhejiang Cancer Hospital
Fujian Cancer Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Anhui Provincial Cancer Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shandong Cancer Hospital and Institute
Jiangxi Provincial Cancer Hospital
Women's Hospital School Of Medicine Zhejiang University
Hebei Medical University Fourth Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Obstetrics & Gynecology Hospital of Fudan University
Fujian Maternity and Child Health Hospital
The Second Affiliated Hospital of Harbin Medical University
West China Second University Hospital
Third Affiliated Hospital of Xinjiang Medical University
Sichuan Cancer Hospital and Research Institute
The Second Affiliated Hospital of Dalian Medical University
Cancer Hospital of Guizhou Province
The Affiliated Ganzhou Hospital of Nanchang University
First Affiliated Hospital of Gannan Medical University
Sun Yat-sen University Cancer Hosptial
Gansu Provincial Maternal and Child Health Care Hospital

Investigators

  • Principal Investigator: Dongling Zou, M.D., Chongqing University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGOG0103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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