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Clinical Trials/JPRN-UMIN000007411
JPRN-UMIN000007411
Completed
Phase 2

A phase II Study of Useful therapeutic strategy for metastatic Colorectal Cancer to Evaluate Oxaliplatin Stop and Go in SOX+Bmab - SUCCESS

wajima City Hospital0 sites50 target enrollmentFebruary 29, 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
wajima City Hospital
Enrollment
50
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 29, 2012
End Date
March 1, 2017
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
wajima City Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\)Contraindication of TS\-1, Oxaliplatin and Bevacizumab. 2\)Patients with severe complications,(heart failure, renal failure, liver failure, peptic ulcer hemorrhage, intestinal paralysis, intestinal obstruction, Peritonitis or uncontrollable diabetes mellitus or hypertension) 3\)Patients with History of severe drug allergy, pulmonary fibrosis, interstitial pneumonitis, Thrombosis/embolism, Cerebral infarction, pulmonary infarction or hemoptysis. 4\)Patients with severe diarrhea 5\) Patients with sensory neuropathy 6\)Patients with serious infections or susupected infections with fever(over 38 degree) 7\)HBs Ag is positive 8\)Complication of ascites or pleural effusion requiring treatment such as the drainage 9\) Patients with the primary tumor with the high\-grade stenosis as an endoscope do not pass.( However, the case of excision of the primary tumor or the stoma is possible.) 10\) Patients with the peritoneal metastasis which we can confirm with an image 11\)concomitant therapy with flucytocine, phenytoin or warfarin 12\)Pregnant, breast feeding, or men in hope of Pregnancy of partner. 13\)Relapse of administering period and less than 6 months of TS\-1 or Oxaliplatin. 14\) Patients with the continuous systemically administration of steroid. 15\) Active concomitant malignancy with less than five years in disease free interval. 16\)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Outcomes

Primary Outcomes

Not specified

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