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Impact of Early FDG-PET- Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study
Primary Objective:
To assess and compare the overall survival (OS) of patients with locally advanced gastric cancer classified as FDG-PET non-responders after one cycle of pre-operative chemotherapy randomly assigned to receive either salvage chemotherapy before and after surgery or immediate surgery followed by fluorouracil sensitized radiotherapy.
Secondary Objectives:
To assess and compare progression-free survival (PFS) between the treatment arms (Arms A and B).
To assess and compare R0 resection rate between the treatment arms (Arms A and B).
To assess and compare pathologic complete response (pCR) rate between the treatment arms (Arms A and B).
To assess the adverse events (AE) profile and safety of each treatment arm (Arms A and B), including post-operative mortality rate, 30-day post-operative targeted adverse events (i.e., dehiscence, significant infection, and re-operation rate).
To examine the changes of FDG-PET SUV induced by pre-operative chemotherapy at different time points (from baseline to completion of one cycle of treatment before randomization, and 2 cycles of salvage treatment) in patients randomized to salvage treatment arm (Arm B).
To collect measurement of fatigue and overall perception of QOL at registration of the study. (Alliance registration QOL assessment study)
Other Objective(s):
Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline QOL and fatigue.
Primary Objective:
To assess and compare the overall survival (OS) of patients with locally advanced gastric cancer classified as FDG-PET non-responders after one cycle of pre-operative chemotherapy randomly assigned to receive either salvage chemotherapy before and after surgery or immediate surgery followed by fluorouracil sensitized radiotherapy.
Secondary Objectives:
To assess and compare progression-free survival (PFS) between the treatment arms (Arms A and B).
To assess and compare R0 resection rate between the treatment arms (Arms A and B).
To assess and compare pathologic complete response (pCR) rate between the treatment arms (Arms A and B).
To assess the adverse events (AE) profile and safety of each treatment arm (Arms A and B), including post-operative mortality rate, 30-day post-operative targeted adverse events (i.e., dehiscence, significant infection, and re-operation rate).
To examine the changes of FDG-PET SUV induced by pre-operative chemotherapy at different time points (from baseline to completion of one cycle of treatment before randomization, and 2 cycles of salvage treatment) in patients randomized to salvage treatment arm (Arm B).
To collect measurement of fatigue and overall perception of QOL at registration of the study. (Alliance registration QOL assessment study)
Other Objective(s):
Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline QOL and fatigue.
Recruitment Status
Past Studies