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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	The concurrent weekly TP regimen	paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m\^2, DDP: 25mg/m\^2) 6 cycles of chemotherapy
RADIATION	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-01-01
• Completion: 2021-05-01
• First posted: 2020-10-19
• Last updated: 2020-10-19

Locations

1 site across 1 country: China