SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer
NCT ID: NCT02870153
Last Updated: 2016-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-01-31
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOX(oxalipaltin+S-1)
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
SOX
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
XELOX (oxalipaltin+capecitabine)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
XELOX
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Interventions
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SOX
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
XELOX
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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The First People's Hospital of Changzhou
OTHER
Responsible Party
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Principal Investigators
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Changping Wu, M.D.
Role: STUDY_DIRECTOR
The First People's Hospital of Changzhou
Locations
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The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Baratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22.
Esquivel J. Colorectal cancer with peritoneal metastases: Progress, not perfection. J Surg Oncol. 2015 Jul;112(1):115. doi: 10.1002/jso.23954. Epub 2015 Jul 7. No abstract available.
Ogawa M, Anan T, Suzuki T, Okuma M, Ichihara K, Hasegawa T, Yoshida K, Yanaga K. Initial Report of Phase II Study on Bi-weekly SOX plus Cetuximab Treatment for Wild-type K-RAS Advanced and Recurrent Colorectal Cancer. Anticancer Res. 2016 May;36(5):2505-11.
Wang ZQ, Zhang DS, Xu N, Luo DY, Deng YH, Wang FH, Luo HY, Qiu MZ, Li YH, Xu RH. Phase II study of oxaliplatin combined with S-1 and leucovorin (SOL) for Chinese patients with metastatic colorectal cancer. Chin J Cancer. 2016 Jan 6;35:8. doi: 10.1186/s40880-015-0061-3.
Other Identifiers
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CZYY-CRC-007
Identifier Type: -
Identifier Source: org_study_id
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