Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung radiofrequency ablation | Device | A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measures:3-year survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Haruyuki Takaki, MD | Department of Radiology, Mie University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo kosei hospital | Anjo | Aichi-ken | 446-8602 | Japan | ||
| Aichi Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17377185 | Background | 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. | |
| 31934829 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Hasegawa 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |