Back to resultsA Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
folfox
short course Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
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
- 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.
Sites / Locations
- Severance Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Response rate (RECIST V1.0)
Overall survival rate
Progression free survival time
Toxicity profile
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01269229
Brief Title
A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Official Title
A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
folfox
Intervention Description
FOLFOX: Day1- Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, 5-FU 400mg/m2 IV bolus -> 2400mg/m2 46hrs continuous
Intervention Type
Radiation
Intervention Name(s)
short course Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
complete resection (R0) rate for rectal and liver lesions.
Description
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.
Time Frame
after surgical resection
Secondary Outcome Measure Information:
Title
Response rate (RECIST V1.0)
Time Frame
every 4 cycles
Title
Overall survival rate
Time Frame
participants will be followed until death
Title
Progression free survival time
Time Frame
participants will be followed until disease progression or death
Title
Toxicity profile
Time Frame
participants will be followed until disease progression or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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.
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
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