A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
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|ClinicalTrials.gov Identifier: NCT01269229|
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : September 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: folfox Radiation: short course Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
- 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.
- 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.
- Response rate (RECIST V1.0) [ Time Frame: every 4 cycles ]
- Overall survival rate [ Time Frame: participants will be followed until death ]
- Progression free survival time [ Time Frame: participants will be followed until disease progression or death ]
- Toxicity profile [ Time Frame: participants will be followed until disease progression or death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269229
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|