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Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

Primary Purpose

Locally Advanced Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Concurrent chemoradiation
Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Cervical Cancer focused on measuring surgery staging, image staging, Locally advanced cervical cancer, PFS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
  2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
  3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;
  4. ECOG score: 0 ~ 1;
  5. The expected survival >6 months;
  6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.

Exclusion Criteria:

  1. Activity or uncontrol severe infection;
  2. Liver cirrhosis or other decompensated liver disease;
  3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
  4. Chronic renal insufficiency or renal failure;
  5. Other malignancies were diagnosed within five years or needed treatments;
  6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
  7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
  8. A history of pelvic artery embolization;
  9. A history of pelvic radiotherapy;
  10. A history of partial hysterectomy or radical hysterectomy;
  11. A history of severe allergic reaction to platinum drugs;
  12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
  13. Patients who cannot understand the research regimen and refuse to sign the informed consent form;
  14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Sites / Locations

  • Chongqing University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Image staging group

Surgery staging group

Arm Description

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

Open/minimally invasive 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

OS
3-year and 5-year Overall Survival
Complication
Some conditions caused by surgery or chemoradiation.

Full Information

First Posted
May 12, 2022
Last Updated
August 29, 2023
Sponsor
Chongqing University Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05378087
Brief Title
Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
Official Title
Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.
Detailed Description
All eligible patients will be divided into the following two treatment groups nonrandomly. Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy). Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer
Keywords
surgery staging, image staging, Locally advanced cervical cancer, PFS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a non-randomized controlled concurrent trial. According to the patients' voluntary choice, they are enrolled on the surgery staging group or image staging group. All patients are evaluated by CT(≥32 slices) or MRI(≥1.5T) or PET/CT. The criteria for positive pelvic or para-aortic lymph nodes (one of the following): ① CT or MRI show more than one positive lymph node with a short diameter ≥ 15mm; ② PET/CT shows more than one positive lymph node with SUV ≥ 2.5; ③ If CT or MRI show positive lymph node with a short diameter between 10mm and 15mm, PET / CT should further verify that it is a positive lymph node with SUV ≥ 2.5.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1956 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Image staging group
Arm Type
Active Comparator
Arm Description
Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Arm Title
Surgery staging group
Arm Type
Experimental
Arm Description
Open/minimally invasive para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Intervention Type
Radiation
Intervention Name(s)
Concurrent chemoradiation
Intervention Description
Standard concurrent chemoradiation: A point/HCR-CTV D90 ≥80Gy (+20%) by using IMRT or TOMO technics. Patients with image-positive common iliac lymph nodes or para-aortic lymph nodes receive extended-field EBRT. Brachytherapy should begin after 15-20F external radiotherapy. A radiation dose for the image-positive nodes can range from 55Gy to 60Gy. Five cycles of concurrent platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period one week) and CCRT should be completed within 56 days. CCRT one week later, if the cervix biopsy shows residual tumour and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes in the pelvic and abdominal cavity, three cycles of adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy will be performed (A point/HR-CTV D90 ≤ 96Gy).
Intervention Type
Procedure
Intervention Name(s)
Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Intervention Description
Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (height of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation should be performed postoperatively within 28 days.) The chemoradiation is consistent with the image staging group, except for extended-field EBRT determined by pathological positive para-aortic lymph nodes.
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
OS
Description
3-year and 5-year Overall Survival
Time Frame
3 years and 5 years
Title
Complication
Description
Some conditions caused by surgery or chemoradiation.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients with good compliance, voluntarily signed the informed consent form and participated in the study. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma Stage (FIGO2018): IB3, IIA2, IIB-IVA; ECOG score: 0 ~ 1; The expected survival >6 months; The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial. Exclusion Criteria: Activity or uncontrol severe infection; Liver cirrhosis or other decompensated liver disease; A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease; Chronic renal insufficiency or renal failure; Other malignancies were diagnosed within five years or needed treatments; Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association); The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive; 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; The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis; Patients who cannot understand the research regimen and refuse to sign the informed consent form; Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongling Zou, M.D.
Phone
13657690699
Email
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 University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongling Zou, M.D.
Phone
13657690699
Email
cqzl_zdl@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study involves confidentiality and patients' privacy protection.
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Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

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