Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
1 other identifier
interventional
70
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Longer than P75 for phase_2
16 active sites
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedMarch 7, 2019
March 1, 2019
9.2 years
October 17, 2008
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measures:3-year survival
3 years
Secondary Outcomes (1)
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
3 years
Study Arms (1)
Lung radiofrequency ablation
EXPERIMENTALA radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Interventions
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mie Universitylead
Study Sites (16)
Anjo kosei hospital
Anjo, Aichi-ken, 446-8602, Japan
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
Hokkaido University
Sapporo, Hokkaido, 060-8648, Japan
Yamada red-cross hospital
Ise, Mie-ken, 516-0805, Japan
Matsusaka munipal hospital
Matsusaka, Mie-ken, 515-0073, Japan
Matsusaka central hospital
Matsusaka, Mie-ken, 515-8566, Japan
Suzuka Kaisei Hospital
Suzuka, Mie-ken, 513-8505, Japan
Suzuka central hospital
Suzuka, Mie-ken, 513-8630, Japan
Toyama hospital
Tsu, Mie-ken, 514-0043, Japan
Mie central medical center
Tsu, Mie-ken, 514-1101, Japan
Mie University
Tsu, Mie-ken, 514-8507, Japan
Mie prefectual medical center
Yokkaichi, Mie-ken, 510-8561, Japan
Okayama University
Kayama, Okayama-ken, 700-8558, Japan
Kumamoto University
Kumamoto, 860-8505, Japan
Kyoto Prefectual University of Kyoto
Kyoto, 602-8566, Japan
Okayama Saiseikai Hospital
Okayama, 700-8511, Japan
Related Publications (2)
Yamakado K, Hase S, Matsuoka T, Tanigawa N, Nakatsuka A, Takaki H, Takao M, Inoue Y, Kanazawa S, Inoue Y, Sawada S, Kusunoki M, Takeda K. Radiofrequency ablation for the treatment of unresectable lung metastases in patients with colorectal cancer: a multicenter study in Japan. J Vasc Interv Radiol. 2007 Mar;18(3):393-8. doi: 10.1016/j.jvir.2006.11.003.
PMID: 17377185BACKGROUNDHasegawa T, Takaki H, Kodama H, Yamanaka T, Nakatsuka A, Sato Y, Takao M, Katayama Y, Fukai I, Kato T, Tokui T, Tempaku H, Adachi K, Matsushima Y, Inaba Y, Yamakado K. Three-year Survival Rate after Radiofrequency Ablation for Surgically Resectable Colorectal Lung Metastases: A Prospective Multicenter Study. Radiology. 2020 Mar;294(3):686-695. doi: 10.1148/radiol.2020191272. Epub 2020 Jan 14.
PMID: 31934829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Haruyuki Takaki, MD
Department of Radiology, Mie University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- instructor of Department of Interventional Radiology
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 21, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2017
Study Completion
August 31, 2018
Last Updated
March 7, 2019
Record last verified: 2019-03