Back to resultsSOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer
Primary Purpose
Colorectal Neoplasm
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SOX
XELOX
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasm
Eligibility Criteria
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
Sites / Locations
- The First People's Hospital of ChangzhouRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SOX(oxalipaltin+S-1)
XELOX (oxalipaltin+capecitabine)
Arm Description
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
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Outcomes
Primary Outcome Measures
Response Rate
According to the RECIST criterion
Secondary Outcome Measures
Side-effect
Safety was evaluated according to the NCI-CTC
Time to Progression
According to the RECIST criterion
Overall Survival
Full Information
NCT ID
NCT02870153
First Posted
August 12, 2016
Last Updated
August 17, 2016
Sponsor
The First People's Hospital of Changzhou
1. Study Identification
Unique Protocol Identification Number
NCT02870153
Brief Title
SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer
Official Title
A Randomized Phase II Study of Oxaliplatin and S-1 (SOX) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Peritoneal Metastasis of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First People's Hospital of Changzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOX(oxalipaltin+S-1)
Arm Type
Experimental
Arm Description
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
Arm Title
XELOX (oxalipaltin+capecitabine)
Arm Type
Active Comparator
Arm Description
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Intervention Type
Drug
Intervention Name(s)
SOX
Other Intervention Name(s)
Eloxatin, TS-1
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
XELOX
Other Intervention Name(s)
Eloxatin, Xeloda
Intervention Description
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Primary Outcome Measure Information:
Title
Response Rate
Description
According to the RECIST criterion
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Side-effect
Description
Safety was evaluated according to the NCI-CTC
Time Frame
8 weeks
Title
Time to Progression
Description
According to the RECIST criterion
Time Frame
6 years
Title
Overall Survival
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiemin Zhao, M.D.
Phone
86-519-68871122
Email
210328010@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liangrong Shi, M.D.
Phone
86-519-68871122
Email
doctorslr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changping Wu, M.D.
Organizational Affiliation
The First People's Hospital of Changzhou
Official's Role
Study Director
Facility Information:
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangrong Shi, M.D.
Phone
86-519-68871122
Email
shiliangr@126.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
26867984
Citation
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.
Results Reference
background
PubMed Identifier
26153356
Citation
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.
Results Reference
background
PubMed Identifier
27127165
Citation
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.
Results Reference
background
PubMed Identifier
26739998
Citation
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.
Results Reference
background
Learn more about this trial
SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer
We'll reach out to this number within 24 hrs