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The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal cancer.
Full description
Peritoneal dissemination from colorectal cancer is common, and it has been traditionally regarded as end-stage disease only amenable to palliation by systemic chemotherapy (sCT), or supportive care .Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.
Enrollment
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Volunteers
Inclusion criteria
Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
Peritoneal metastasis of colorectal cancer
At least one uni-dimensional measurable lesion by RECIST criteria
Age 18 to 80 years old
Estimated life expectancy ≥3 months
ECOG performance status ≤2
Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
Adequate kidney function (creatinine < 1.5 mg/dL)
Adequate liver function (bilirubin < 2.0 mg/dL, transaminase levels <2.5 times the upper normal limit)
Written informed consent
Exclusion criteria
Other tumor type than adenocarcinoma
Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
Presence of CNS metastasis, psychosis, or seizure
Obvious bowel obstruction
Evidence of serious gastrointestinal bleeding
Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Central trial contact
Jiemin Zhao, M.D.; Liangrong Shi, M.D.
Data sourced from clinicaltrials.gov
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