Clinical trial NCT04121975: CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer
Official title: Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: progression-free survival (PFS) rate at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 year
measure: Overall survival
timeFrame: 2 year
measure: Treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Hanmei Lou, PHD
role: PRINCIPAL_INVESTIGATOR
References: