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NCT Number: NCT04555226

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location status: Recruiting

Location contact

Dongling Zou, M.D.

CONTACT

[email protected]

13657690699

Dongling Zou, M.D.

PRINCIPAL_INVESTIGATOR

Misi He, M.M.

SUB_INVESTIGATOR

Ying Tang, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • 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
  • No surgical contraindication

Exclusion criteria

  • 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
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Chronic renal insufficiency or renal failure
  • Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
  • Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
  • Has had an allogenic tissue/solid organ transplant
  • A history of pelvic artery embolization
  • A history of pelvic radiotherapy
  • A history of partial hysterectomy or radical hysterectomy
  • A history of immunotherapy or undergoing immunotherapy
  • A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and/or any excipients
  • During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Treatment and study plan

Lymph Node Dissection

Procedure

Open/minimaly invasive pelvic and para-aortic lymph node dissection

Standard chemoradiation±pembrolizumab

Radiation
  • 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.

Chemoradiation± pembrolizumab

Radiation
  • 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.

Primary outcomes

  1. PFS

    Time frame: 2 years

    Progression-free survival

Secondary outcomes

  1. OS

    Time frame: 3 and 5 years

    Overall survival

Study contacts

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

Dongling Zou, M.D.

CONTACT

[email protected]

13657690699

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2029
Study completion
2032
First posted
Sep 18, 2020
Registry last updated
Sep 2, 2025

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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