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Clinical Trials/JPRN-jRCTs021180034
JPRN-jRCTs021180034
Suspended
Phase 2

Phase II study of resection of primary colorectal caner and synchronous liver metastasis after S-1 + oxaliplatin (SOX) + Bevacizumab(Bmab) therapy and adjuvant S-1 chemotherapy - Colorectal cancer with synchronous liver metastasis

Morohashi Hajime0 sites28 target enrollmentStarted: March 25, 2019Last updated:

Overview

Phase
Phase 2
Status
Suspended
Sponsor
Morohashi Hajime
Enrollment
28

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to <= 75age old (—)
Sex
All

Inclusion Criteria

  • 1\) Hitologically confirmed colon or rectal cancer
  • 2\) With priary lesion on colon or rectal cancer
  • 3\) With primary and synchronous liver metastasis without other metastasis
  • 4\) With evaluable lesion
  • 5\) Where a surgeon judged hepatectomy is possible. As a measure of initially unresectable liver metastasis, it is assumed that the residual liver volume after hepatectomy is expected to be less than 30% even by portal vein embolism
  • 6\) Without extrahepatic lesions other than the primary lesion
  • 1\. Without pulmpnary metastasis by X\-P or CT
  • 2\. Without hepatic and paraaortic lymph node swelling by CT
  • 7\) Age of 20\-75 years
  • 8\) Without prior anti\-tumor therapy (radiation therapy, chemotherapy and hormone therapy)

Exclusion Criteria

  • 1\) with gastrointestinal ulceration or bleeding
  • 2\) with sensory neuropathy
  • 3\) with severe diarrhea
  • 4\) had a previous serious drug allergies
  • 5\) had pleural effusion or ascites which need therapy
  • 6\) with brain metastasis or suspected the brain metastases
  • 7\) had surgery within 28 days before registration
  • 8\) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
  • 9\) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
  • 10\) with active double cancer

Investigators

Sponsor
Morohashi Hajime

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