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| ID | Type | Description | Link |
|---|---|---|---|
| UWASH-1200 | |||
| CWRU-040106 | |||
| UWASH-440E-ONC-0020-250 | |||
| NCI-G01-2045 | |||
| CWRU-UWMC-1200 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells.
PURPOSE: Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to treatment with radiofrequency ablation in addition to resection (yes vs no).
Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8 weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan hydrochloride | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| radiofrequency ablation | Procedure |
DISEASE CHARACTERISTICS:
Histologically confirmed primary colorectal adenocarcinoma
Hepatic metastases that are considered completely resectable
Hepatic metastases that are not completely resectable but are amenable to complete destruction with resection and radiofrequency ablation
No extrahepatic disease in any location
No recurrent or second primary colorectal cancer by colonoscopy within the past year
Received prior adjuvant chemotherapy with a fluorouracil-based regimen with the last dose at least 1 month prior to surgery
No prior radiofrequency ablation with residual viable intrahepatic disease by CT scan
No plans to be treated with radiofrequency ablation alone without surgical resection
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin G. Billingsley, MD | University of Washington | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States | ||
| University of Washington School of Medicine |
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| Seattle |
| Washington |
| 98195 |
| United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D017024 | Chemotherapy, Adjuvant |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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