Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.

Peking University Third Hospital0 sites64 target enrollmentJune 2024

Overview

Brief Summary

Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.

Registry

clinicaltrials.gov

Start Date

June 2024

End Date

October 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Peking University Third Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system;
•(2) Eastern Cooperative Oncology Group at 2 or less;
•(3) Life expectancy of greater than 3 months;
•(4) Left ventricular ejection fraction at ≥55%;
•(5) Neutrophil count at ≥1500/mm\^3, platelet count at ≥100,000/mm\^3 or hemoglobin at ≥9.0 g/dL;
•(6) Serum creatinine at \<1.5 times the upper limit of the normal reference range;
•(7) Alanine transaminase or aspartate aminotransferase at \>2.5 times the upper limit of the normal reference range;
•(8) Non pregnant or lactating women;
•(9) Women of childbearing age willing to adopt reliable contraceptive measures;
•(10) Sign informed consent form.

Exclusion Criteria

•(1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;
•(2) Individuals who have previously received abdominal or pelvic radiation therapy;
•(3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy;
•(4) Individuals with central nervous system diseases or brain metastases；
•(5) Other malignant tumors other than cervical cancer have appeared within the past 5 years;
•(6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ;
•(7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc;
•(8) known to be allergic to paclitaxel;
•(9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration;
•(10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia;

Arms & Interventions

Experimental group

Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).

Intervention: radiotherapy

Experimental group

Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).

Intervention: Nab paclitaxel

Experimental group

Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).

Intervention: Cisplatin