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A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis (NCT03022734)

The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.
  • Drug: chemotherapy
    cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)
    • Radiation: radiotherapy
      After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.
      Ages eligible for Study
      19 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      Inclusion Criteria:
      • pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
      • over 19 years
      • Eastern Cooperative Oncology Group 0-1
      • Proper organ function
      • more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
      • Who should sign on the Informed consent form before participate the trial.
      Exclusion Criteria:
      • Metastasis in other organ except liver
      • Chronic active hepatitis or cirrhosis
      • History of treatment for metastatic colorectal cancer
      • Subject pregnant or breast feeding
      • Uncontrolled disease
      • Have had adjuvant therapy
      • Uncontrolled peripheral nerve infection
      • Alcoholic or drug addict
      • Subject currently is enrolled in or ≤30 days from ending other clinical trial.
      • History of other type of cancer except resolved from skin cancer and cervical cancer.

      1 locations

      Korea, Republic of (1)
      • Severance Hospital, Yonsei University Health System
        Seoul, Korea, Republic of, 03722
      31 August, 2016
      10 January, 2018
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