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

Yonsei University

Status and phase

Completed

Phase 2

Conditions

Rectal Cancer

Treatments

Radiation: short course Radiotherapy

Drug: folfox

Study type

Interventional

Funder types

Other

Identifiers

NCT01269229

4-2009-0522

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.