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

NCT ID: NCT04121975

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-08-31

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.

Endostar

Intervention Type: DRUG

30 mg/d was administered on days 1-5 every two weeks for 4 cycles.

Cisplatin

Intervention Type: DRUG

30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Interventions

Radiotherapy

Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.

Intervention Type: RADIATION

Endostar

30 mg/d was administered on days 1-5 every two weeks for 4 cycles.

Intervention Type: DRUG

Cisplatin

30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Intervention Type: DRUG

Other Intervention Names

Recombinant human endostatin

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanmei Lou, PHD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hanmei Lou, PHD

Role: CONTACT

louhm@zjcc.org.cn

+86-13456856364

Facility Contacts

Hanmei Lou, PHD

Role: primary

louhm@zjcc.org.cn

+86-13456856364

Other Identifiers

Endo-CC-01

Identifier Type: -

Identifier Source: org_study_id