Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study

Zhejiang Cancer Hospital1 site in 1 country82 target enrollmentAugust 1, 2019

Overview

Brief Summary

This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.

Detailed Description

This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. Cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.

Registry

clinicaltrials.gov

Start Date

August 1, 2019

End Date

August 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age from 18 to 65 years old;
•Histologically confirmed to be cervical squamous cell carcinoma;
•Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);
•The ECOG PS score is 0 or 1;
•At least one measurable (measured according to RECIST 1.1);
•No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc;
•This treatment must be the first course of treatment;
•The expected survival expectation is not less than 6 months;
•The main organ function meets the following criteria within 7 days before treatment:
•Blood routine examination standard (without blood transfusion within 14 days):

Exclusion Criteria

•Patients with distant metastases;
•Those suffering from other malignant tumors;
•Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;
•Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;
•During pregnancy or lactation;
•Those who have received targeted therapy;
•Those who are in other drug trials;
•Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
•It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;

Arms & Interventions

Chemoradiotherapy

Radiation: Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles. Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Intervention: Radiotherapy

Chemoradiotherapy

Radiation: Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles. Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Intervention: Endostar

Chemoradiotherapy

Radiation: Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles. Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Intervention: Cisplatin