MedTrace Logo

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

NCT01269229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-09-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269229 on ClinicalTrials.gov