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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01269229
Collaborator
(none)
32
Enrollment
1
Location
62.9
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Outcome Measures

Primary Outcome Measures

  1. complete resection (R0) rate for rectal and liver lesions. [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

  1. Response rate (RECIST V1.0) [every 4 cycles]

  2. Overall survival rate [participants will be followed until death]

  3. Progression free survival time [participants will be followed until disease progression or death]

  4. Toxicity profile [participants will be followed until disease progression or death]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Severance Hospital Seoul Korea, Republic of 120-752

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01269229
Other Study ID Numbers:
  • 4-2009-0522
First Posted:
Jan 4, 2011
Last Update Posted:
Sep 7, 2016
Last Verified:
Sep 1, 2016
Additional relevant MeSH terms:
Rectal Neoplasms

Study Results

No Results Posted as of Sep 7, 2016