Clinical trial NCT03266042: Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy
Official title: Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Malignant Neoplasm Primary Non-Resectable
Lead sponsor: Delcath Systems Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received or will receive treatment with CHEMOSAT for the Treatment of Unresectable Hepatic Malignancy

Brief summary: Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Detailed description: Post Marketing study:

The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.

This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.

Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.

The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.

Eligibility criteria: 1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.
2. Have provided written informed consent according to institutional and regulatory guidelines

Primary outcomes:
measure: Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
timeFrame: Post-procedure (up to 30 days after CS-PHP)
Secondary outcomes:
measure: Percentage of treatment with CHEMOSAT each patient receives
timeFrame: From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
measure: Evaluation of Best Overall Response
timeFrame: from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
measure: Evaluation of resource utilization
timeFrame: From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]
measure: Evaluate time to treatment failure
timeFrame: time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals and University of Southampton
city: Southampton
country: United Kingdom
facility: Spire Southampton Hospital
Study officials:
References: