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The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
salvage surgery
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Locally advanced cervical cancer, chemoradiotherapy, redsidual tumor, salvage sugery, OS

Eligibility Criteria

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

Inclusion Criteria: Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma. Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy). After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment. ECOG score:0 ~ 1. The expected survival time>6 months; There is no absolute contraindication of surgery and the patients with good compliance. Exclusion Criteria: The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached. PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes. Other malignancies were diagnosed within five years or needed treatments. History of important organ transplantation. History of immune disease who need to take immunosuppressive drugs. History of serious mental illness and brain functional disorder. Drug abuse or drug use history. Participants in other clinical trials at the same time. Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements. Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians. 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.

Sites / Locations

  • Chongqing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

salvage sugery

Arm Description

Salvage surgery for patients diagnosed locally advanced cervical cancr with residual tumor after standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+ brachytherapy)

Outcomes

Primary Outcome Measures

OS
5 years overall survival

Secondary Outcome Measures

PFS
Progression-free survival

Full Information

First Posted
February 20, 2023
Last Updated
October 6, 2023
Sponsor
Chongqing University Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05749887
Brief Title
The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.
Official Title
Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
July 1, 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
This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Locally advanced cervical cancer, chemoradiotherapy, redsidual tumor, salvage sugery, OS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
salvage sugery
Arm Type
Other
Arm Description
Salvage surgery for patients diagnosed locally advanced cervical cancr with residual tumor after standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+ brachytherapy)
Intervention Type
Procedure
Intervention Name(s)
salvage surgery
Intervention Description
Open/minimally invasive salvage surgery performed when cervical biopsy and/or PET/CT scan ( SUVmax ≥2.5 ) indicate patients with residual tumor intrapelvic 4-12 weeks after standard CCRT. Surgery type: No parametrial involvement, extrafascial hysterectomy; There is parametrial involvement, extensive hysterectomy(Q-MC); Only bladder invasion, anterior pelvic exenteration; Only rectal invasion, posterior pelvic exenteration or total pelvic exenteration; Invasion of bladder and rectum, total exenteration. The pelvic lymph nodes are removed at the same time when 18F -FDG PET /CT indicates that the SUVmax is ≥ 2.5.
Primary Outcome Measure Information:
Title
OS
Description
5 years overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma. Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy). After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment. ECOG score:0 ~ 1. The expected survival time>6 months; There is no absolute contraindication of surgery and the patients with good compliance. Exclusion Criteria: The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached. PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes. Other malignancies were diagnosed within five years or needed treatments. History of important organ transplantation. History of immune disease who need to take immunosuppressive drugs. History of serious mental illness and brain functional disorder. Drug abuse or drug use history. Participants in other clinical trials at the same time. Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements. Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians. 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, PH.D
Phone
13657690699
Email
cqzl_zdl@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongling Zou, PH.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongling Zou, PH.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
Zou Dongling, PH.D.
Phone
+8613657690699
Email
cqzl_zdl@163.com

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.

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