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.
NCT ID: NCT04588090
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-01-01
2021-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
The concurrent 3 weeks treatment group（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy）
The concurrent 3 weeks TP regimen
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 radiation plus intraluminal after-loading irradiation
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.
Standard chemoradiation group
Standard chemoradiation（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy）
The concurrent weekly TP regimen
paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m\^2, DDP: 25mg/m\^2) 6 cycles of chemotherapy
External radiation plus intraluminal after-loading irradiation
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.
Interventions
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The concurrent 3 weeks TP regimen
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.
The concurrent weekly TP regimen
paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m\^2, DDP: 25mg/m\^2) 6 cycles of chemotherapy
External radiation plus intraluminal after-loading irradiation
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.
Eligibility Criteria
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Inclusion Criteria
2. New cervical squamous cell carcinoma cases between 18 and 70 years old;
3. Clinical stages: stage ⅡB-stage ⅢB;
4. PS score is less than 2 points;
5. Expected survival is over 3 months;
6. Blood routine: Hb≥70g/L, WBC≥3.5×10\^9/L, ANC≥1.5×10\^9/L, PLT≥80×10\^9/L
7. Serum ALT and AST≤2×ULN; serum creatinine≤1.5×ULN;
8. 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;
9. Patients who can comply with the trial protocol (judged by the investigator).
Exclusion Criteria
2. Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
3. A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
4. Chronic renal insufficiency and renal failure;
5. Pregnant woman;
6. Myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (New York Heart Association (NYHA) classification);
7. Patients receiving targeted therapy and pelvic artery embolism;
8. Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
9. Those who have received radiotherapy for malignant pelvic tumors in the past;
10. Patients with autoimmune system diseases such as systemic lupus erythematosus;
11. Patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis;
12. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent;
13. Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
18 Years
70 Years
FEMALE
No
Sponsors
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Chongqing University Cancer Hospital
OTHER
Responsible Party
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Dongling Zou
Director
Locations
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Countries
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Other Identifiers
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CQGOG0105
Identifier Type: -
Identifier Source: org_study_id
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