A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: folfox
* Radiation: short course Radiotherapy


Participation Criteria
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Eligibility Criteria
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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 ECOG 0-1 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. History of other type of cancer except resolved from skin cancer and cervical cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: folfox|FOLFOX: Day1- Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, 5-FU 400mg/m2 IV bolus -> 2400mg/m2 46hrs continuous|
|Radiation: short course Radiotherapy|After FOLFOX 4cycle, subject have short course RTx 5Gy at once this should be continuing for 5days so that subject should have 25Gy within 5days. Then, subjects have another 4 cycle of FOLFOX and evaluate cancer for resection.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resection (R0) rate for rectal and liver lesions. | 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. | after surgical resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RECIST V1.0) |  | every 4 cycles | 
| Overall survival rate |  | participants will be followed until death | 
| Progression free survival time |  | participants will be followed until disease progression or death | 
| Toxicity profile |  | participants will be followed until disease progression or death |