SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer

NCT02870153 | Unknown Phase 2 DMC

• 1 other identifier: CZYY-CRC-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasm

Outcome Measures

Primary Outcomes (1)

• Response Rate

  According to the RECIST criterion

  6 weeks

Secondary Outcomes (3)

• Side-effect

  8 weeks

• Time to Progression

  6 years

• Overall Survival

  6 years

Study Arms (2)

SOX(oxalipaltin+S-1)

EXPERIMENTAL

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

Drug: SOX

XELOX (oxalipaltin+capecitabine)

ACTIVE COMPARATOR

Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days

Drug: XELOX

Interventions

SOX DRUG

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

Also known as: Eloxatin, TS-1

SOX(oxalipaltin+S-1)

XELOX DRUG

Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days

Also known as: Eloxatin, Xeloda

XELOX (oxalipaltin+capecitabine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

RECRUITING

Related 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.

  PMID: 26867984 BACKGROUND

• 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.

  PMID: 26153356 BACKGROUND

• 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.

  PMID: 27127165 BACKGROUND

• 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.

  PMID: 26739998 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; titanium silicide; XELOX; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Changping Wu, M.D.

  The First People's Hospital of Changzhou

  STUDY DIRECTOR

Central Study Contacts

Jiemin Zhao, M.D.

CONTACT

86-519-68871122; 210328010@163.com

Liangrong Shi, M.D.

CONTACT

86-519-68871122; doctorslr@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: January 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)