NCT00594529

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 23, 2011

Status Verified

August 1, 2009

Enrollment Period

2.3 years

First QC Date

January 4, 2008

Last Update Submit

June 22, 2011

Conditions

Colorectal CancerLiver Metastasis

Keywords

Neoadjuvant chemotherapyMetastatic liver lesions from colorectal cancers

Outcome Measures

Primary Outcomes (1)

  • Curative resection rates of liver metastases

    2 years after the operations

Secondary Outcomes (1)

  • Completion rates of neoadjuvant chemotherapy

    2 years after the operation

Study Arms (1)

1

OTHER
Procedure: Surgery

Interventions

SurgeryPROCEDURE

Liver resection for metastatic liver lesions

1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, 606-8507, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27752787DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Satoshi Nagayama, Assistant

CONTACT

+81-75-751-3227nagayama@kuhp.kyoto-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2013

Last Updated

June 23, 2011

Record last verified: 2009-08

Locations

JP(1)