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

This study is currently recruiting participants.
Verified March 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01269229
First received: January 3, 2011
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: participants will be followed until death ] [ Designated as safety issue: No ]
  • Progression free survival time [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269229

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woong-Sub Koom, MD, Ph.D     82-2-2228-8116        
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01269229     History of Changes
Other Study ID Numbers: 4-2009-0522
Study First Received: January 3, 2011
Last Updated: March 21, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasm Metastasis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013