Rectal Cancer
Conditions
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.
Interventions
DRUGfolfox
FOLFOX: Day1- Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, 5-FU 400mg/m2 IV bolus -\> 2400mg/m2 46hrs continuous
RADIATIONshort 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.
Sponsors
Yonsei University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete resection (R0) rate for rectal and liver lesions. | 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
| Measure | Time frame |
|---|---|
| Overall survival rate | participants will be followed until death |
| Response rate (RECIST V1.0) | every 4 cycles |
| Progression free survival time | participants will be followed until disease progression or death |
| Toxicity profile | participants will be followed until disease progression or death |
Countries
South Korea
Outcome results
None listed