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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121975
• Other study ID #: Endo-CC-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: August 2022

Study information

• Verified date: October 2019
• Source: Zhejiang Cancer Hospital
• Contact: Hanmei Lou, PHD
• Phone: +86-13456856364
• Email: louhm[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 65 years old;

2. Histologically confirmed to be cervical squamous cell carcinoma;

3. Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);

4. The ECOG PS score is 0 or 1;

5. At least one measurable (measured according to RECIST 1.1);

6. No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc;

7. This treatment must be the first course of treatment;

8. The expected survival expectation is not less than 6 months;

9. The main organ function meets the following criteria within 7 days before treatment:

Blood routine examination standard (without blood transfusion within 14 days):

1. hemoglobin (HB) = 90g / L;

2. neutrophil absolute value (ANC) = 1.5 × 10 9 / L;

3. platelets (PLT) = 80 × 10 9 / L.

Biochemical tests are subject to the following criteria:

1. total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN);

2. alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5 times ULN;

3. 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:

1. Patients with distant metastases;

2. Those suffering from other malignant tumors;

3. Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;

4. Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;

5. During pregnancy or lactation;

6. Those who have received targeted therapy;

7. Those who are in other drug trials;

8. Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;

9. It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Radiotherapy
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.
• Cisplatin
30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS) rate at 1 year	The rates of patients who were progression free at 1-year after enrollment	1 year
Secondary	Progression-free survival	Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.	2 year
Secondary	Overall survival	Overall survival was defined as the time from enrollment to death from any cause	2 year
Secondary	Treatment-related adverse events as assessed by CTCAE v4.0	Treatment-related adverse events	1 year