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

NCT ID: NCT01269229

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

folfox

FOLFOX: Day1- Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, 5-FU 400mg/m2 IV bolus -\> 2400mg/m2 46hrs continuous

Intervention Type: DRUG

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2009-0522

Identifier Type: -

Identifier Source: org_study_id