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

Sponsor
Chongqing University Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04555226
Collaborator
Sun Yat-sen University (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Jiangxi Maternal and Child Health Hospital (Other), Jiangxi Provincial Cancer Hospital (Other), Anhui Provincial Cancer Hospital (Other), Harbin Medical University (Other), Hebei Medical University Fourth Hospital (Other), Zhejiang Cancer Hospital (Other), Women's Hospital School Of Medicine Zhejiang University (Other), Qilu Hospital of Shandong University (Other), Fujian Cancer Hospital (Other), The Third Affiliated Hospital of Kunming Medical College. (Other), Sichuan Cancer Hospital and Research Institute (Other), Cancer Hospital of Guizhou Province (Other), West China Second University Hospital (Other), Tongji Hospital (Other), The Affiliated Ganzhou Hospital of Nanchang University (Other), First Affiliated Hospital of Gannan Medical University (Other), Gansu Provincial Maternity and Child-Care Hospital (Other), Third Affiliated Hospital of Xinjiang Medical University (Other), Affiliated Cancer Hospital of Shantou University Medical College (Other), Obstetrics & Gynecology Hospital of Fudan University (Other)
452
Enrollment
1
Location
2
Arms
102.6
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lymph node dissection
  • Radiation: Standard chemoradiation
  • Radiation: Chemoradiation
 N/A

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).

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
452 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer
Actual Study Start Date :
Jan 11, 2021
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard treatment group

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

Radiation: Standard chemoradiation
A point/HCR-CTV D90 ≥80Gy（+20%） Extended-field EBRT: image-positive common iliac lymph nodes with short diameter ≥10mm and/or image-positive para-aortic lymph node Target doses for the image-positive nodes can range from 55 to 60Gy Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week) CCRT will be completed in 56 days After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed.
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).

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

Radiation: Chemoradiation
A point/HCR-CTV D90 ≥80Gy（+20%） Extended-field EBRT: Pathlogical positive para-aortic lymph node Target doese for pelvic and/or abdomal lymph nodes is usually 45Gy. After operation, the residual lymph node need to be labeled and the target doses for it ranges from 55-60Gy. Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week) CCRT will be completed in 56 days After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed.

Outcome Measures

Primary Outcome Measures

  1. PFS [2 years]

    Progression-free survival

Secondary Outcome Measures

  1. OS [3 and 5 years]

    Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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. Liver cirrhosis, Decompensated liver disease

  3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease

  4. Chronic renal insufficiency or renal failure

  5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated

  6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure

  7. A history of pelvic artery embolization

  8. A history of pelvic radiotherapy

  9. A history of partial hysterectomy or radical hysterectomy

  10. A history of severe allergic reaction to platinum drugs

  11. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chongqing Cancer Hospital Chongqing Chongqing China 400030

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
ClinicalTrials.gov Identifier:
NCT04555226
Other Study ID Numbers:
  • CQGOG0103
First Posted:
Sep 18, 2020
Last Update Posted:
Apr 7, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
Stage IIICr of cervical cancer
Lymph node dissection
Chemoradiation
PFS
Additional relevant MeSH terms:
Uterine Cervical Neoplasms

Study Results

No Results Posted as of Apr 7, 2022