Cervical Cancer
Conditions
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.
Interventions
RADIATIONRadiotherapy
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
DRUGEndostar
30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
DRUGCisplatin
30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) rate at 1 year | 1 year | The rates of patients who were progression free at 1-year after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 year | Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause. |
| Overall survival | 2 year | Overall survival was defined as the time from enrollment to death from any cause |
| Treatment-related adverse events as assessed by CTCAE v4.0 | 1 year | Treatment-related adverse events |
Countries
China
Contacts
Primary ContactHanmei Lou, PHD
Outcome results
None listed