XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .
Study rationale : Park et al. observed the oxaliplatin as part of XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. The response with XELOX regimen generally occurs earlier. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. This regimen was studied in colon and breast cancer. \- Objective: Primary: To evaluate progression free survival Secondary: To evaluated overall survival, response rate, toxicity profile of chemotherapy, quality of life * Design :Multicenter randomized controlled phase III open label trial Study subjects will be randomized to two groups in a ratio of 1:1 Subjects More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-complete response/non-progressive disease in cases of non-measurable disease before XELOX chemotherapy), * Treatment Groups Group A : Capecitabine: Capecitabine 1000mg/m2 bid D1-14, q 3 week Group B : Observation * Evaluation of response and toxicity A response will be evaluated radiologically every two cycles thereafter, or when progression is suspicious by RECIST criteria version 1.1. A progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause. An overall survival is defined as the time from the 1stdate of chemotherapy to the date of death. Safety will be evaluated every treatment by NCI-CTCAE version 4.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
maintenance capecitabine therapy after six cycles of XELOX
St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
RECRUITINGBuchon St. Mary's Hospital
Buchon, South Korea
RECRUITINGDaejeon St. Mary's Hospital
Daejeon, South Korea
RECRUITINGIncheon St. Mary's Hospital
Incheon, South Korea
RECRUITINGSeoul St. Mary's Hospital
Seoul, South Korea
RECRUITINGSt. Mary's Hospital
Seoul, South Korea
RECRUITINGBundang Seoul National hospital
Sungnam, South Korea
RECRUITINGUjeongbu St. Mary's Hospital
Ujeongbu, South Korea
RECRUITINGProgression free survival
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Overall survival
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
quality of life in patients measured by QLQ-c30 and STO-22
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
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