The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer (CQGOG0102)
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CCRT
Paclitaxel, Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Locally adcanced, CCRT, Adjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- Complete CCRT(Radiation Does: A point 85Gy(+/-10%),B点50Gy(+/-10%),concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
- MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
- ECOG<2
- Expected survival is longer than six months
- Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
- ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
- 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
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
- Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
- Have suffered or combined with other malignant tumor
- Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- A history targeted therapy or pelvic artery embolization
- Artery-enous thrombosis within 6 months
- Patients with autoimmune diseases
- Complications, need to be treatment with drugs which may lead to liver or kidney injury
- Patients with disease progression after chemoradiation
Sites / Locations
- Chongqing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
trial group
Arm Description
In this group, observation is given after CCRT.
In this group, adjuvant chemotherapy is given after CCRT.
Outcomes
Primary Outcome Measures
PFS
Progression-free survival
Secondary Outcome Measures
OS
5 years overall survival
ORR
To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer
Full Information
NCT ID
NCT04409860
First Posted
May 23, 2020
Last Updated
April 8, 2023
Sponsor
Chongqing University Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04409860
Brief Title
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Acronym
CQGOG0102
Official Title
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2029 (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 aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.
Detailed Description
Objective:
To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.
Patients:
Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy(cisplatin or carboplatin)
MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
Methods:
The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Locally adcanced, CCRT, Adjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
In this group, observation is given after CCRT.
Arm Title
trial group
Arm Type
Experimental
Arm Description
In this group, adjuvant chemotherapy is given after CCRT.
Intervention Type
Radiation
Intervention Name(s)
CCRT
Other Intervention Name(s)
control group: CCRT + observation
Intervention Description
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Cisplatin
Other Intervention Name(s)
trial group: CCRT + adjuvant chemotherapy
Intervention Description
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Description
5 years overall survival
Time Frame
5 years
Title
ORR
Description
To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer
Time Frame
3 months
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:
Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
Complete CCRT(Radiation Does: A point 85Gy(+/-10%),B点50Gy(+/-10%),concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
ECOG<2
Expected survival is longer than six months
Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
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
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
Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
Have suffered or combined with other malignant tumor
Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
A history targeted therapy or pelvic artery embolization
Artery-enous thrombosis within 6 months
Patients with autoimmune diseases
Complications, need to be treatment with drugs which may lead to liver or kidney injury
Patients with disease progression after chemoradiation
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 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
Email
cqzl_zdl@163.com
First Name & Middle Initial & Last Name & Degree
Dongling Zou, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
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