Ovarian Cancer Clinical Trial
Official title:
Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer: A Randomized Controlled Trial
It is a prospective multi-center trial, platinum-resistant ovarian cancer patients will be randomized in two groups, one group will be treated with Apatinib plus Etoposide, the other will be treated with Etoposide alone. It is aimed to see the efficacy and safety of Apatinib plus Etoposide for the platinum-resistant ovarian cancer patients
It is a randomized controlled trial, the aim is to see the efficacy and safety of Apatinib
plus Etoposide treating platinum-resistant ovarian cancer. The main primary end point is DCR
(disease control rate), the secondary endpoint is Duration of response（DOR），overall survival
(OS), time to progression (TTP)，quality of life (QoL, according to EORTC QLQ-C30).The key
safety indicators include the patients' vital signs, laboratory indicators, adverse
events(AE),serious adverse events.
The data collection duration is from the day ICF assigned to the day(30 days after the end of
the last medication).From the day ICF signed to the end of the study, all adverse events were
recorded in the CRF. The severity of the adverse events will be evaluated according to the
NCI CTCAE 4.0 standard.Each patient will receive a planned visit and specific data at
different points will be recorded in the visit.
The patients will be followed up after quitting the trial because of disease progression or
intolerance. The following parameters were recorded during follow-up: disease
recurrence,metastasis,death time,SAE occurred during the study; survival (available with
telephone follow-up, record required).
Adverse events that have not been recovered when the drug is discontinued should be tracked
and finalized. All patients should undergo a 30-day follow-up after the last medication to
find any new adverse events.
All cases should be recorded carefully and completely, the investigator should be responsible
for the authenticity of the center's data.
During the clinical trial, the inspector should send the CRF to the data management unit (in
batches), the data administrator will carry out the independent double entry, and carry out
the double verification.
The trial as an exploratory test, using a small sample comparison, the test plans to enroll a
total of 60 cases.
The statistical analysis plan includes case analysis,demographic data and baseline
analysis,efficacy analysis and safety analysis.All statistical tests will be performed on
both sides, the difference between the tests was considered statistically significant with a
P value less than or equal to 0.05,
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