Colorectal Cancer Clinical Trial
Official title:
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
Verified date | March 2019 |
Source | Mie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Mie University |
Japan,
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
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 |
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 |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
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 |