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

NCT04555226 | Recruiting

• 1 other identifier: CQGOG0103
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

Stage IIICr of cervical cancer; Lymph node dissection; Chemoradiation; PFS

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  2 years

Secondary Outcomes (1)

• OS

  3 and 5 years

Study Arms (2)

Standard treatment group

ACTIVE COMPARATOR

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

Radiation: Standard chemoradiation±pembrolizumab

Experimental group

EXPERIMENTAL

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; Radiation: Chemoradiation± pembrolizumab

Interventions

Lymph node dissection PROCEDURE

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

Experimental group

Standard chemoradiation±pembrolizumab RADIATION

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.

Standard treatment group

Chemoradiation± pembrolizumab RADIATION

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 group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead
• 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 Hosptial: collaborator

Study Sites (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Related Publications (13)

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• He M, Guo M, Zhou Q, Tang Y, Zhong L, Liu Q, Fan X, Zhao X, Zhang X, Chen G, Shen Y, Xu Q, Chen X, Li Y, Zou D. Efficacy of lymph node dissection on stage IIICr of cervical cancer before CCRT: study protocol for a phase III, randomized controlled clinical trial (CQGOG0103). J Gynecol Oncol. 2023 May;34(3):e55. doi: 10.3802/jgo.2023.34.e55. Epub 2023 Mar 23.

  PMID: 36998225 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Dongling Zou, M.D.

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongling Zou, M.D.

CONTACT

13657690699; cqzl_zdl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecologic Oncology Department

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: January 11, 2021
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2032
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)