CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer

Study 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.

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

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Radiation: Radiotherapy
* Drug: Endostar
* Drug: Cisplatin


Participation Criteria
=================
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): hemoglobin (HB) ≥ 90g / L; neutrophil absolute value (ANC) ≥ 1.5 × 10 9 / L; platelets (PLT) ≥ 80 × 10 9 / L. Biochemical tests are subject to the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 times ULN; serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance (CCr) ≥ 60ml / min; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%). (10) Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment And must be non-lactating patients; (11) Can understand the study and have signed an informed consent form; 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemoradiotherapy<br>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. | Radiation: Radiotherapy<br>* Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.<br>Drug: Endostar<br>* 30 mg/d was administered on days 1-5 every two weeks for 4 cycles.<br>* Other names: Recombinant human endostatin;Drug: Cisplatin<br>* 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) rate at 1 year | The rates of patients who were progression free at 1-year after enrollment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause. | 2 year | 
| Overall survival | Overall survival was defined as the time from enrollment to death from any cause | 2 year | 
| Treatment-related adverse events as assessed by CTCAE v4.0 | Treatment-related adverse events | 1 year |