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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269229
First Posted: January 4, 2011
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose

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.


Condition Intervention Phase
Rectal Cancer Drug: folfox Radiation: short course Radiotherapy Phase 2

Study Type: Interventional
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

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: January 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269229


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01269229     History of Changes
Other Study ID Numbers: 4-2009-0522
First Submitted: January 3, 2011
First Posted: January 4, 2011
Last Update Posted: September 7, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases