Clinical trial NCT00776399: Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
Official title: Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Metastasis
Colorectal Cancer
Keywords: Colorectal cancer
lung metastasis
radiofrequency ablation
metastasectomy
Lung metastasis from colorectal cancer
Lead sponsor: Mie University
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Primary Outcome Measures:3-year survival
timeFrame: 3 years
Secondary outcomes:
measure: Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
timeFrame: 3 years
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Anjo kosei hospital
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University
state: Hokkaidou
city: Ise
country: Japan
facility: Yamada red-cross hospital
state: Mie
city: Matsusaka
country: Japan
facility: Matsusaka munipal hospital
state: Mie
city: Matsusaka
country: Japan
facility: Matsusaka central hospital
state: Mie
city: Suzuka
country: Japan
facility: Suzuka Kaisei Hospital
state: Mie
city: Suzuka
country: Japan
facility: Suzuka central hospital
state: Mie
city: Tsu
country: Japan
facility: Toyama hospital
state: Mie
city: Tsu
country: Japan
facility: Mie central medical center
state: Mie
city: Tsu
country: Japan
facility: Mie University
state: Mie
city: Yokkaichi
country: Japan
facility: Mie prefectual medical center
state: Mie
city: Kayama
country: Japan
facility: Okayama University
state: Okayama
city: Kumamoto
country: Japan
facility: Kumamoto University
city: Kyoto
country: Japan
facility: Kyoto Prefectual University of Kyoto
city: Okayama
country: Japan
facility: Okayama Saiseikai Hospital
Study officials:
affiliation: Department of Radiology, Mie University School of Medicine
name: Haruyuki Takaki, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.