Back to resultsA Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The concurrent 3 weeks TP regimen
The concurrent weekly TP regimen
External radiation plus intraluminal after-loading irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- The patient participated in this study voluntarily and all volunteers will sign the informed consent.
- New cervical squamous cell carcinoma cases between 18 and 70 years old;
- Clinical stages: stage ⅡB-stage ⅢB;
- PS score is less than 2 points;
- Expected survival is over 3 months;
- Blood routine: Hb≥70g/L, WBC≥3.5×10^9/L, ANC≥1.5×10^9/L, PLT≥80×10^9/L
- Serum ALT and AST≤2×ULN; serum creatinine≤1.5×ULN;
- Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial;
- Patients who can comply with the trial protocol (judged by the investigator).
Exclusion Criteria:
- Active or uncontrolled serious infection;
- Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
- A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
- Chronic renal insufficiency and renal failure;
- Pregnant woman;
- Myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (New York Heart Association (NYHA) classification);
- Patients receiving targeted therapy and pelvic artery embolism;
- Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
- Those who have received radiotherapy for malignant pelvic tumors in the past;
- Patients with autoimmune system diseases such as systemic lupus erythematosus;
- Patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis;
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent;
- Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
Sites / Locations
- Chongqing Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Standard chemoradiation group
Arm Description
The concurrent 3 weeks treatment group（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy）
Standard chemoradiation（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy）
Outcomes
Primary Outcome Measures
disease control rate (DCR)
Including the percentage of patients with complete remission, partial remission or with stable disease state and maintained for more than 4 weeks among the patients with evaluable efficacy.
Objective response rate (ORR)
Including the percentage of patients with complete remission or partial remission and maintained for more than 4 weeks among the patients with evaluable efficacy.
Secondary Outcome Measures
progression-free survival (PFS)
the time from patient randomization to objective progression or death.
overall survival (OS)
the time from the beginning of enrollment to death for any reason. For subjects who are lost to follow-up, the time of last follow-up is usually calculated as the time of death.
Full Information
NCT ID
NCT04588090
First Posted
September 30, 2020
Last Updated
October 8, 2020
Sponsor
Chongqing University Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04588090
Brief Title
A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.
Official Title
A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (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 main purpose for this experiments are as follows: 1. Patients with stage ⅡB-ⅢB cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined TP regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. All enrolled patients will be tested for HPV subtype infection; the relationship between the sensitivity and curative effect of concurrent radiotherapy and chemotherapy will be analyzed, and at the end of the test, HPV subtypes will be tested again and changes will be analyzed to provide more clinical evidence for the reasonable comprehensive treatment and precision medical treatment of advanced cervical squamous cell carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The concurrent 3 weeks treatment group（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy）
Arm Title
Standard chemoradiation group
Arm Type
Placebo Comparator
Arm Description
Standard chemoradiation（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy）
Intervention Type
Procedure
Intervention Name(s)
The concurrent 3 weeks TP regimen
Intervention Description
paclitaxel + cisplatin regimen (TP-TAX: 150mg/m^2, DDP: 70mg/m^2 (35mg/m^2, d1, d2), 1 time/3 weeks) chemotherapy for 2 cycles.
Intervention Type
Procedure
Intervention Name(s)
The concurrent weekly TP regimen
Intervention Description
paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m^2, DDP: 25mg/m^2) 6 cycles of chemotherapy
Intervention Type
Radiation
Intervention Name(s)
External radiation plus intraluminal after-loading irradiation
Intervention Description
External radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation.
Primary Outcome Measure Information:
Title
disease control rate (DCR)
Description
Including the percentage of patients with complete remission, partial remission or with stable disease state and maintained for more than 4 weeks among the patients with evaluable efficacy.
Time Frame
1 month and 3 months
Title
Objective response rate (ORR)
Description
Including the percentage of patients with complete remission or partial remission and maintained for more than 4 weeks among the patients with evaluable efficacy.
Time Frame
1 month and 3 months
Secondary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
the time from patient randomization to objective progression or death.
Time Frame
2 years
Title
overall survival (OS)
Description
the time from the beginning of enrollment to death for any reason. For subjects who are lost to follow-up, the time of last follow-up is usually calculated as the time of death.
Time Frame
3 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:
The patient participated in this study voluntarily and all volunteers will sign the informed consent.
New cervical squamous cell carcinoma cases between 18 and 70 years old;
Clinical stages: stage ⅡB-stage ⅢB;
PS score is less than 2 points;
Expected survival is over 3 months;
Blood routine: Hb≥70g/L, WBC≥3.5×10^9/L, ANC≥1.5×10^9/L, PLT≥80×10^9/L
Serum ALT and AST≤2×ULN; serum creatinine≤1.5×ULN;
Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial;
Patients who can comply with the trial protocol (judged by the investigator).
Exclusion Criteria:
Active or uncontrolled serious infection;
Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
Chronic renal insufficiency and renal failure;
Pregnant woman;
Myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (New York Heart Association (NYHA) classification);
Patients receiving targeted therapy and pelvic artery embolism;
Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
Those who have received radiotherapy for malignant pelvic tumors in the past;
Patients with autoimmune system diseases such as systemic lupus erythematosus;
Patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis;
Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent;
Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
Facility Information:
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.
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