- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04588090
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.
October 8, 2020 updated by: Dongling Zou, Chongqing University Cancer Hospital
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Chongqing
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Chongqing, Chongqing, China, 400030
- Chongqing Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
The concurrent 3 weeks treatment group(external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy)
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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.
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.
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PLACEBO_COMPARATOR: Standard chemoradiation group
Standard chemoradiation(external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy)
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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.
paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m^2, DDP: 25mg/m^2) 6 cycles of chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease control rate (DCR)
Time Frame: 1 month and 3 months
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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.
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1 month and 3 months
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Objective response rate (ORR)
Time Frame: 1 month and 3 months
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Including the percentage of patients with complete remission or partial remission and maintained for more than 4 weeks among the patients with evaluable efficacy.
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1 month and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival (PFS)
Time Frame: 2 years
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the time from patient randomization to objective progression or death.
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2 years
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overall survival (OS)
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ANTICIPATED)
January 1, 2021
Study Completion (ANTICIPATED)
May 1, 2021
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
October 8, 2020
First Posted (ACTUAL)
October 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- CQGOG0105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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