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A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

after surgical resection

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2009-0522

NCT ID:

NCT01269229

Start Date:

January 2010

Completion Date:

June 2012

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms
  • Neoplasm Metastasis

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