Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With … (NCT00020501) | Clinical Trial Compass
CompletedPhase 3
Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver
United StatesStarted 2001-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver
* No evidence of extrahepatic disease (limited resectable extrahepatic disease allowed)
* Unresectable liver metastasis, as defined by the following:
* More than 3 sites of disease
* Bilobar disease
* Tumor abutting major vascular or ductal structures
* Measurable disease
* No biopsy-proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices, or collateral vessels around organs drained by the portal venous system
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count greater than 100,000/mm\^3
* Hematocrit greater than 27.0%
* WBC greater than 3,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL
* PT no greater than 2 seconds over upper limit of normal
* Elevations in transaminases secondary to metastatic disease allowed
* No veno-occlusive disease
* No active chronic hepatitis
* Hepatitis B or C allowed provided there is no evidence of cirrhosis
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No ischemic cardiac disease
* No prior congestive heart failure with LVEF less than 40%
Pulmonary:
* No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function test less than 50% of predicted
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00020501
SponsorNational Institutes of Health Clinical Center (CC)