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Search / Trial NCT02870153

SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer

Launched by THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU · Aug 12, 2016

Trial Information

Current as of July 05, 2025

Unknown status

Keywords

ClinConnect Summary

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 di...

Gender

ALL

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

About The First People's Hospital Of Changzhou

The First People's Hospital of Changzhou is a leading healthcare institution dedicated to advancing medical research and enhancing patient care through innovative clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals to conduct rigorous research across various therapeutic areas. Committed to ethical standards and patient safety, the First People's Hospital of Changzhou fosters collaboration with academic institutions and industry partners to drive medical breakthroughs and improve therapeutic outcomes for diverse patient populations.

Locations

Changzhou, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Changping Wu, M.D.

Study Director

The First People's Hospital of Changzhou

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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