Lung MetastasisPhase 2NCT00776399
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
A Phase 2 study testing Lung radiofrequency ablation in people with Lung Metastasis and Colorectal Cancer, run by Mie University at 16 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Metastasis, Colorectal Cancer
- What is being tested?
- Lung radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 16 sitesJapan
- Study dates
- Oct 2008to 31 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Anjo kosei hospital
Anjo, Aichi-ken, 446-8602
Yamada red-cross hospital
Ise, Mie-ken, 516-0805
Okayama University
Kayama, Okayama-ken, 700-8558
Kumamoto University
Kumamoto, 860-8505
Kyoto Prefectual University of Kyoto
Kyoto, 602-8566
Matsusaka munipal hospital
Matsusaka, Mie-ken, 515-0073
Matsusaka central hospital
Matsusaka, Mie-ken, 515-8566
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Okayama Saiseikai Hospital
Okayama, 700-8511
Hokkaido University
Sapporo, Hokkaido, 060-8648
Suzuka Kaisei Hospital
Suzuka, Mie-ken, 513-8505
Suzuka central hospital
Suzuka, Mie-ken, 513-8630
Toyama hospital
Tsu, Mie-ken, 514-0043
Mie central medical center
Tsu, Mie-ken, 514-1101
Mie University
Tsu, Mie-ken, 514-8507
Mie prefectual medical center
Yokkaichi, Mie-ken, 510-8561
About this study
Official title: Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: 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 phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.
Read the 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.
- Conditions
- Lung Metastasis, Colorectal Cancer
- Being tested
- Lung radiofrequency ablation
- Keywords
- Colorectal cancer, lung metastasis, radiofrequency ablation, metastasectomy, Lung metastasis from colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung radiofrequency ablationDevice
Also called Cool-tip radiofrequency ablation system is used.
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
| Study group | Role | What they receive |
|---|---|---|
| Lung radiofrequency ablation | Experimental | A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis. Receives: Device: Lung radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures:3-year survival
Measured: 3 years
Secondary outcomes (1)
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2008
- Primary completion1 Dec 2017
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichiro Yamakado, Mie University
- Investigators
- Haruyuki Takaki, MD, Study director, Department of Radiology, Mie University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776399
- Sponsor's protocol ID
- 2008-993 Mie-U-IRB
- Status last verified
- Mar 2019
- First submitted
- 17 Oct 2008
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17377185Hasegawa 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.
PubMed 31934829
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
- ClinicalTrials.gov ID
- NCT00776399
- Acronym / sponsor ID
- 2008-993 Mie-U-IRB
- Conditions
- Lung Metastasis, Colorectal Cancer
- Keywords
- Colorectal cancer, lung metastasis, radiofrequency ablation, metastasectomy, Lung metastasis from colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mie UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung radiofrequency ablation | Experimental | Device: Lung radiofrequency ablationA radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung radiofrequency ablationAlso: Cool-tip radiofrequency ablation system is used.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 |
Primary outcome
Primary Outcome Measures:3-year survival
Time frame: 3 years
1 secondary outcome
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Background: PubMed 17377185Yamakado 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.
- Derived from this study: PubMed 31934829Hasegawa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haruyuki Takaki, MD study director
Department of Radiology, Mie University School of Medicine
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lung radiofrequency ablation in people with Lung Metastasis and Colorectal Cancer, run by Mie University at 16 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures:3-year survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776399, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.