A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Yonsei University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- complete resection (R0) rate for rectal and liver lesions.
- Status
- Completed
- Last Updated
- 9 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. The subject should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
This trial contributes to save the time for decreasing primary tumor in rectal and metastasis cancer to whole body after short course radiotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject whom should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
- •Over 18 years
- •Proper organ function (hepatic transaminases : \< ULN ⅹ5, Bilirubin: \< ULNⅹ2, creatinine (serum): \< ULNⅹ 1.5, PLT \> 100,000Ul, ANC \> 1,500/Ul
- •more than one target lesion (standard by RECIST 1.0)
- •Who should sign on the Informed consent form before participate the trial.
Exclusion Criteria
- •Metastasis in other organ except liver (No matter whether have resection or not)
- •Chronic active hepatitis or cirrhosis
- •History of treatment for colorectal cancer
- •Subject pregnant or breast feeding
- •Uncontrolled disease (eg. infection, hypertension, heart failure, Myocardial Infarction within 6months)
- •Have been used FOLFOX as an adjuvant therapy
- •Have had adjuvant therapy within 6months
- •Uncontrolled peripheral nerve infection
- •Alcoholic or drug addict
- •Subject currently is enrolled in or ≤30 days from ending other clinical trial.
Outcomes
Primary Outcomes
complete resection (R0) rate for rectal and liver lesions.
Time Frame: after surgical resection
Complete resection (R0 resection) is defined as no residual cancer cells in the resection margn both primary recal mass and liver metastases after simultaneous surgical resection.
Secondary Outcomes
- Overall survival rate(participants will be followed until death)
- Response rate (RECIST V1.0)(every 4 cycles)
- Toxicity profile(participants will be followed until disease progression or death)
- Progression free survival time(participants will be followed until disease progression or death)