NCT03022734
Unknown
Phase 2
A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Overview
- Phase
- Phase 2
- Intervention
- chemotherapy
- Conditions
- Rectal Cancer, Metastatic
- Sponsor
- Yonsei University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- complete resection (R0) rate for rectal and liver lesions
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Sang Joon Shin
Professor
Yonsei University
Eligibility Criteria
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.
Arms & Interventions
chemotherapy with radiotherapy
Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
Intervention: chemotherapy
chemotherapy with radiotherapy
Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
Intervention: radiotherapy
Outcomes
Primary Outcomes
complete resection (R0) rate for rectal and liver lesions
Time Frame: after surgical resection, an average of 24 weeks
Secondary Outcomes
- Response rate (RECIST V1.1)(8 weeks)
Study Sites (1)
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