MedTrace Logo

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.

NCT04588090 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chongqing University Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2021-01-01
Completion
2021-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588090 on ClinicalTrials.gov