Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00776399
Other study ID # 2008-993 Mie-U-IRB
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2008
Est. completion date August 31, 2018

Study information

Verified date March 2019
Source Mie University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. In this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 31, 2018
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Japan Anjo kosei hospital Anjo Aichi
Japan Yamada red-cross hospital Ise Mie
Japan Okayama University Kayama Okayama
Japan Kumamoto University Kumamoto
Japan Kyoto Prefectual University of Kyoto Kyoto
Japan Matsusaka central hospital Matsusaka Mie
Japan Matsusaka munipal hospital Matsusaka Mie
Japan Aichi Cancer Center Nagoya Aichi
Japan Okayama Saiseikai Hospital Okayama
Japan Hokkaido University Sapporo Hokkaidou
Japan Suzuka central hospital Suzuka Mie
Japan Suzuka Kaisei Hospital Suzuka Mie
Japan Mie central medical center Tsu Mie
Japan Mie University Tsu Mie
Japan Toyama hospital Tsu Mie
Japan Mie prefectual medical center Yokkaichi Mie

Sponsors (1)

Lead Sponsor Collaborator
Mie University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measures:3-year survival 3 years
Secondary Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A