SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer

Colorectal Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02870153
• Other study ID #: CZYY-CRC-007
• Status: Recruiting
• Phase: Phase 2
• First received: August 12, 2016
• Last updated: August 17, 2016
• Start date: January 2013
• Est. completion date: June 2019

Study information

• Verified date: August 2016
• Source: The First People's Hospital of Changzhou
• Contact: Jiemin Zhao, M.D.
• Phone: 86-519-68871122
• Email: 210328010[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	According to the RECIST criterion	6 weeks	No
Secondary	Side-effect	Safety was evaluated according to the NCI-CTC	8 weeks	Yes
Secondary	Time to Progression	According to the RECIST criterion	6 years	No
Secondary	Overall Survival		6 years	No