A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
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.
|Rectal Cancer||Drug: folfox Radiation: short course Radiotherapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis|
- 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 ]
|Study Start Date:||January 2010|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269229
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|