Study of Cetuximab Plus P-HDFL for the First-Line Treatment of Advanced Gastric Cancer
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The primary end point of the study is confirmed objective response rate (complete response
[CR] and partial response [PR]). A response rate of 80 percent for cetuximab plus cisplatin
and weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (P-HDFL) chemotherapy
is assumed. The Simon two-stage design will be used for P1 - P0 = 0.20. The response rates of
interest are P0 = 60% and P1 = 80%. The investigators will reject cetuximab plus P-HDFL
chemotherapy if the response rate is 8/13 at the first stage, and will reject the cetuximab
plus P-HDFL chemotherapy if the response rate is 25/35 at the second stage. If there are more
than 8 responses in 13 patients in the first stage, the study will continue to a total of 35
patients in the second stage. If there are more than 25 responses in 35 patients in the
second stage, this treatment will be acceptable with a p-value of 0.05 and of 0.20. Evaluable
patients for response will be those who received at least 4 doses of cetuximab (i.e. one
cycle of protocol treatment). All enrolled patients will be subjected to toxicity
evaluations.
The primary end point of the study is confirmed objective response rates (by RECIST, Response
Evaluation Criteria in Solid Tumors). The secondary end points of the study are
progression-free survival, overall survival, and treatment-related toxicities.
The analysis of response to treatment will be restricted to the eligible patients with at
least one measurable lesion. The safety analysis will be restricted to the patients who
received at least one cycle of the administered chemotherapy. The time-to-event end points
will be estimated using the method of Kaplan and Meier and based on the intent-to-treat
principle. Overall survival will be defined as the time interval between the date of study
entry and the date of death. Progression-free survival will be defined as the time interval
between the date of study entry and the date of disease progression or death, whichever
occurred first. Duration of response will be defined as the time interval between the date of
initial objective response and the date of disease progression, which is only for responders.
If the event is not yet observed at the time of the last record, the patient will be censored
at that time point.