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Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers

Primary Purpose

Colorectal Cancer, Liver Metastasis

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Surgery
Sponsored by
Kyoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
  2. Liver lesions are measurable by spiral CT or SPIO-MRI scans.
  3. Extrahepatic lesions include lung metastases which can be resected curatively.
  4. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
  5. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
  6. No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
  7. Performance status (ECOG): 0-1
  8. Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.

Exclusion Criteria:

Excluded are cases with conditions as below:

  1. Peritoneal or pleural fluid retention to be drained.
  2. Multiple malignancies to be treated.
  3. Peripheral neural disturbances.
  4. Active infectious diseases.
  5. Severe watery diarrhea.
  6. Mental disturbances.
  7. Treatment history of continuous, oral or intravenous steroid therapy.
  8. Previous history of ischemic heart diseases.
  9. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
  10. Pregnant.
  11. Previous history of severe drug-induced allergy.

Sites / Locations

  • Kyoto University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Curative resection rates of liver metastases

Secondary Outcome Measures

Completion rates of neoadjuvant chemotherapy

Full Information

First Posted
January 4, 2008
Last Updated
June 22, 2011
Sponsor
Kyoto University
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1. Study Identification

Unique Protocol Identification Number
NCT00594529
Brief Title
Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kyoto University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastasis
Keywords
Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Liver resection for metastatic liver lesions
Primary Outcome Measure Information:
Title
Curative resection rates of liver metastases
Time Frame
2 years after the operations
Secondary Outcome Measure Information:
Title
Completion rates of neoadjuvant chemotherapy
Time Frame
2 years after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers. Liver lesions are measurable by spiral CT or SPIO-MRI scans. Extrahepatic lesions include lung metastases which can be resected curatively. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection Performance status (ECOG): 0-1 Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved. Exclusion Criteria: Excluded are cases with conditions as below: Peritoneal or pleural fluid retention to be drained. Multiple malignancies to be treated. Peripheral neural disturbances. Active infectious diseases. Severe watery diarrhea. Mental disturbances. Treatment history of continuous, oral or intravenous steroid therapy. Previous history of ischemic heart diseases. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure. Pregnant. Previous history of severe drug-induced allergy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satoshi Nagayama, Assistant
Phone
+81-75-751-3227
Email
nagayama@kuhp.kyoto-u.ac.jp
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoshi Nagayama, Assistant
Phone
+81-75-751-3227
Email
nagayama@kuhp.kyoto-u.ac.jp

12. IPD Sharing Statement

Citations:
PubMed Identifier
27752787
Citation
Nagayama S, Hasegawa S, Hida K, Kawada K, Hatano E, Nakamura K, Seo S, Taura K, Yasuchika K, Matsuo T, Zaima M, Kanazawa A, Terajima H, Tada M, Adachi Y, Nishitai R, Manaka D, Yoshimura T, Doi K, Horimatsu T, Mitsuyoshi A, Yoshimura K, Niimi M, Matsumoto S, Sakai Y, Uemoto S. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol. 2017 Apr;22(2):316-323. doi: 10.1007/s10147-016-1050-5. Epub 2016 Oct 17.
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Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers

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