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Fase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases


- candidate number15029
- NTR NumberNTR4050
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jun-2013
- Secondary IDsNL45013.058.13 
- Public TitleFase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases
- Scientific TitleFase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases
- ACRONYMCS-IHP-Melfalan
- hypothesisPercutaneous chemosaturation of only the liver in patients with irresectabe colorectal metastases will be safe and effective and lead to downstaging of the tumor andprevent systemic toicity
- Healt Condition(s) or Problem(s) studiedIrresectabel colorectal livermetastases
- Inclusion criteria- Liver metastases of histologically confirmed primary colorectal adenocarcinoma;
- Resection of primary tumor > 1 month before IHP;
- Irresectable metastases confined to the liver based on CT-Thorax/abdomen and PET imaging;
- Metastases measurable on CT-scan;
- Informed consent;
- Life expectancy > 4 months;
- Leukocytes ≥ 3.0 X 10^9/L;
- Thrombocytes ≥ 100 X 10^9/L;
- Creatinine clearance ≥ 40 ml/min;
- Bilirubin <17 µmol/L;
- APTT < 32.5 sec;
- PT < 13.7 sec;
- Exclusion criteriaBiological age <18 and >65 years
- WHO performance status ≥ 2 (Appendix A);
- < 40% healthy liver tissue;
- Aberrant vascular anatomy, which impedes IHP (e.g. aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections);
- Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections, other liver disease);
- Incompetent / Mentally disabled;
- Pregnancy, inadequate anticonception.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-okt-2014
- Target number of participants34
- InterventionsPercutaneous isolated hepatic perfusion/chemosaturation of the liver; The principle of IHP is to shut the liver off of the systemic circulation by performing an operation. Subsequently the liver is flushed for an hour with a very high dose of chemotherapy, which would be toxic and lead to fatal complications when administered systemic. Then the liver is connected to the systemic circulation again.
- Primary outcome• Response rate expressed by RECIST criteria, after two percutaneous liver perfusions with melphalan at a six week interval;
• Number of curative resections after percutaneous perfusion.
- Secondary outcome• Safety of percutaneous liver perfusions with the Delcath 2nd generation system;
• Overall survival and overall progression free survival;
• Duration of response and duration of stable disease;
• Quality of life.
- Timepoints• After 6 weeks;
• Every 3 months in the first year;
• Then once a half year;
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.M. de Leede
- CONTACT for SCIENTIFIC QUERIES E.M. de Leede
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Delcath
- PublicationsN/A
- Brief summaryMalignancies of the liver are the third most important cause of cancer-related deaths in the world. This kind of cancer can be primary (origin in the liver) of secondary (metastases from another part of the body). The most common form of primary liver cancer is the hepatocellular carcinoma (HCC) en the most common form of secondary liver cancer are metastases of colorectal carcinoma (CRCLM). About 30-50% of all patients with colorectal cancer, develop liver metastases synchronous: 14.5-25%, metachronous: 14.5-25%). Patients with liver metastases of colorectal carcinoma often have a bad prognosis, and for these patients surgical resection is the only curative option, despite the constant innovations in chemotherapy. The surgical treatment offers an acceptable morbidity, mortality and the 5-year survival is around 40-50%. Unfortunately only 20-25% of the patients with CRCLM qualify for surgery. The other patients can only be treated with chemotherapy. A part of the patients treated with chemotherapy and with initially irresectable metastases, become operable because of the response to chemotherapy. The disadvantage of systemic administration of chemotherapy in the treatment of liver metastases is that, because of systemic toxicity, the maximum tolerated dose is reached earlier than the minimum effective dose. To accomplish better results with patients with irresectable metastases confined to the liver, isolated hepatic perfusion ( IHP) has been developed. The principle of IHP is to shut the liver off of the systemic circulation by performing an operation. Subsequently the liver is flushed for an hour with a very high dose of chemotherapy, which would be toxic and lead to fatal complications when administered systemic. Then the liver is connected to the systemic circulation again. Because this procedure is associated with considerable morbidity (20%) and mortality (7%), a new procedure was developed by Delcath in which the hepatic perfusion can be performed percutaneous. Expected is that both morbidity and mortality will decrease significantly. In addition, this procedure can be performed several times.
- Main changes (audit trail)
- RECORD23-jun-2013 - 8-jul-2013


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