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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGprogression-free survival (PFS) rate at 1 year
The rates of patients who were progression free at 1-year after enrollment
Time frame: 1 year
Progression-free survival
Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.
Time frame: 2 year
Overall survival
Overall survival was defined as the time from enrollment to death from any cause
Time frame: 2 year
Treatment-related adverse events as assessed by CTCAE v4.0
Treatment-related adverse events
Time frame: 1 year
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