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

Primary Purpose

Cervical Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lymph node dissection

Standard chemoradiation

Chemoradiation

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Stage IIICr of cervical cancer, Lymph node dissection, Chemoradiation, PFS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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
Liver cirrhosis, Decompensated liver disease
History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
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
A history of pelvic artery embolization
A history of pelvic radiotherapy
A history of partial hysterectomy or radical hysterectomy
A history of severe allergic reaction to platinum drugs
During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Sites / Locations

Chongqing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard treatment group

Experimental group

Arm Description

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

Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Outcomes

Primary Outcome Measures

PFS

Progression-free survival

Secondary Outcome Measures

Overall survival

Full Information

NCT ID

NCT04555226

First Posted

September 14, 2020

Last Updated

September 4, 2023

Sponsor

Chongqing University Cancer Hospital

Collaborators

Sun Yat-sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangxi Provincial Cancer Hospital, Anhui Provincial Cancer Hospital, The Second Affiliated Hospital of 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, 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 Maternal and Child Health Care Hospital, Third Affiliated Hospital of Xinjiang Medical University, Affiliated Cancer Hospital of Shantou University Medical College, Obstetrics & Gynecology Hospital of Fudan University, The Second Affiliated Hospital of Dalian Medical University, Fujian Maternity and Child Health Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04555226

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chongqing University Cancer Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

452 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard treatment group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Intervention Type

Procedure

Intervention Name(s)

Lymph node dissection

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Standard chemoradiation

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Chemoradiation

Intervention Description

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.

Primary Outcome Measure Information:

Title

PFS

Description

Progression-free survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Description

Overall survival

Time Frame

3 and 5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Liver cirrhosis, Decompensated liver disease History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease 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 A history of pelvic artery embolization A history of pelvic radiotherapy A history of partial hysterectomy or radical hysterectomy A history of severe allergic reaction to platinum drugs During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dongling Zou, M.D.

Phone

13657690699

cqzl_zdl@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

Organizational Affiliation

Chongqing University Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chongqing Cancer Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

Phone

13657690699

cqzl_zdl@163.com

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

First Name & Middle Initial & Last Name & Degree

Ying Tang, M.D.

First Name & Middle Initial & Last Name & Degree

Misi He, M.M.

12. IPD Sharing Statement

Plan to Share IPD

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

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