Trial record 1 of 1 for:    NCT00776399
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Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

This study is currently recruiting participants.
Verified January 2014 by Mie University
Sponsor:
Information provided by (Responsible Party):
Koichiro Yamakado, Mie University
ClinicalTrials.gov Identifier:
NCT00776399
First received: October 17, 2008
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.


Condition Intervention Phase
Lung Metastasis
Colorectal Cancer
Device: Lung radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial

Resource links provided by NLM:


Further study details as provided by Mie University:

Primary Outcome Measures:
  • Primary Outcome Measures:3-year survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2008
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung radiofrequency ablation
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Device: Lung radiofrequency ablation
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Other Name: Cool-tip radiofrequency ablation system is used.

Detailed Description:

This will be a phase-II clinical trial.

Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this clinical trial, clinical utility of lung RF ablation will be evaluated.

Patients with resectable lung metastases will receive lung RF ablation.

All subjects will be followed for overall survival, safety, change in respiratory function, cancer-specific survival, and local tumor progression.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary lesions (colorectal cancer) are resected.
  • Lung metastases appear.
  • No extrapulmonary metastases or after locoregional treatments.
  • Lung metastasis is considered to be controllable either by metastasectomy or radiofrequency (RF) ablation.
  • Five or less lung metastases measuring 3cm or smaller.
  • PET study within 8 weeks before metastasectomy or RF ablation.
  • White blood count of 3000/mm3 or more.
  • Platelet count of 100,000/mm3 or more.
  • Hemoglobin level of 8.0 g/dl.
  • Serum creatinine level of 2.0 mg/dl or less.
  • PaO2 of 70 mm Hg or more(Room air)or SpO2 of 93%.
  • Serum bilirubin level of 2.0 mg/dl or less.
  • Performance status of 0 or 1.
  • Expected survival of 1 year or more.
  • Age of 20 years or more.
  • Informed consent from the patient.

Exclusion Criteria:

  • Risk to injure lung vessels 5 mm or larger.
  • Lung metastases adjacent to the heart, trachea, esophagus, and aorta.
  • Association of uncontrollable malignancies.
  • Lung hilar lymph node metastasis.
  • One lung.
  • Pulmonary hypertension.
  • Coagulopathy.
  • Impossible to stop using anticoagulants.
  • Active infection or C-reactive protein of 3 or higher.
  • Association of active inflammation.
  • Fever (higher than 38 degrees celsius).
  • Previous external-beam radiotherapy for the treated lung.
  • Pregnant.
  • Judgment to be an inappropriate candidate by a attending physician.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776399

Contacts
Contact: Koichiro Yamakado, MD +81-59-231-5029 yama@clin.medic.mie-u.ac.jp
Contact: Haruyuki Takaki, MD +81-59-231-5029 takaki-h@clin.medic.mie-u.ac.jp

Locations
Japan
Anjo kosei hospital Recruiting
Anjo, Aichi, Japan, 446-8602
Contact: Kazuya Fujinaga, MD    0566-75-2111    fkazuya2002@yahoo.co.jp   
Principal Investigator: Kazuya Fujinaga, MD         
Aichi Cancer Center Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Yoshitaka Inaba, MD    +81-52-762-6111    105824@aichi-cc.jp   
Hokkaido University Recruiting
Sapporo, Hokkaidou, Japan, 060-8648
Contact: Tadashi Shimizu, MD    +81-11-716-1161    tshim@radi.med.hokudai.ac.jp   
Yamada red-cross hospital Recruiting
Ise, Mie, Japan, 516-0805
Contact: Toshiya Tokui, MD    +81-596-28-2171    t-tokui@hotmail.co.jp   
Principal Investigator: Toshiya Tokui, MD         
Matsusaka central hospital Recruiting
Kawaimachi, Matsusaka, Mie, Japan, 515-8566
Contact: Yoshihiko Katayama, MD    +81-598-21-5252    kataccho0209@yahoo.co.jp   
Principal Investigator: Makoto Iwata, MD         
Suzuka Kaisei Hospital Recruiting
Suzuka, Mie, Japan, 513-8505
Contact: Yashushi Matsushima, MD    +81-59-375-1212    matsu-8@kaiseihp.com   
Principal Investigator: Yasushi Matsushima, MD         
Suzuka central hospital Recruiting
Suzuka, Mie, Japan, 513-8630
Contact: Ichiro Fukai, MD    +81-59-382-1311    ifukai@sch.miekosei.or.jp   
Principal Investigator: Ichiro Fukai, MD         
Matsusaka munipal hospital Recruiting
Tonomachi, Matsusaka, Mie, Japan, 515-0073
Contact: Osamu Hataji, MD    +81-598-23-1515      
Principal Investigator: Osamu Hataji, MD         
Mie central medical center Recruiting
Tsu, Mie, Japan, 514-1101
Contact: Masanori Kaneda, MD    +81-59-259-1211    kanedam@miechuo-m.hosp.go.jp   
Principal Investigator: Masanori Kaneda, MD         
Mie University Recruiting
Tsu, Mie, Japan, 514-8507
Contact: Koichiro Yamakado, MD    +81-59-231-5029    yama@clin.medic.mie-u.ac.jp   
Contact: Haruyuki Takaki, MD    +81-59-231-5029    takaki-h@clin.medic.mie-u.ac.jp   
Principal Investigator: Koichiro Yamakado, MD         
Toyama hospital Recruiting
Tsu, Mie, Japan, 514-0043
Contact: Toshio Kato, MD    +81-59-227-6171    md-katoh@toyama-hp.or.jp   
Principal Investigator: Toshio Kato, MD         
Mie prefectual medical center Recruiting
Yokkaichi, Mie, Japan, 510-8561
Contact: Hironori Tenpaku, MD    +81-59-345-2321    tenpakuhironori@yahoo.co.jp   
Sub-Investigator: Hironori Tenpaku, MD         
Okayama University Recruiting
Kayama, Okayama, Japan, 700-8558
Contact: Hideo Gobara, MD    +81-86-235-7315    gobara@cc.okayama-u.ac.jp   
Kumamoto University Recruiting
Kumamoto, Japan, 860-8505
Contact: Osamu Ikeda, MD    +81-96-373-5261    osamu-3643ik@do9.enjoy.ne.jp   
Kyoto Prefectual University of Kyoto Recruiting
Kyoto, Japan, 602-8566
Contact: Takushi Yamagami, MD    +81-75-251-5620    yamagami@koto.kpu-m.ac.jp   
Okayama Saiseikai Hospital Recruiting
Okayama, Japan, 700-8511
Contact: Kotaro Yasui, MD    +81-86-252-2211    yasui@saiseidr.jp   
Sponsors and Collaborators
Mie University
Investigators
Study Director: Haruyuki Takaki, MD Department of Radiology, Mie University School of Medicine
  More Information

Publications:
Responsible Party: Koichiro Yamakado, instructor of Department of Interventional Radiology, Mie University
ClinicalTrials.gov Identifier: NCT00776399     History of Changes
Other Study ID Numbers: 2008-993 Mie-U-IRB
Study First Received: October 17, 2008
Last Updated: January 29, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Mie University:
Colorectal cancer
lung metastasis
radiofrequency ablation
metastasectomy
Lung metastasis from colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Lung Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014