Colorectal Neoplasm
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGSOX
Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days
DRUGXELOX
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Sponsors
The First People's Hospital of Changzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 6 weeks | According to the RECIST criterion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-effect | 8 weeks | Safety was evaluated according to the NCI-CTC |
| Time to Progression | 6 years | According to the RECIST criterion |
| Overall Survival | 6 years | — |
Countries
China
Contacts
Primary ContactJiemin Zhao, M.D.
Backup ContactLiangrong Shi, M.D.
Outcome results
None listed