The Swedish Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
Information provided by (Responsible Party):
Roger Olofsson, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01785316
First received: February 1, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in patients with isolated liver metastases from uveal melanoma.


Condition Intervention Phase
Melanoma
Uveal Neoplasms
Procedure: IHP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    OS defined as the frequency of individuals alive at 24 months


Secondary Outcome Measures:
  • Hepatic progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Defined as time from randomization to progress of existing lesions, or appearance of new lesions, within the liver according to RECIST criteria (version 1.1) using CT or MRI.

  • Response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Defined as best response according to RECIST criteria (version 1.1) using CT or MRI. For the BAC-group, during the whole follow-up of 24 months. For the IHP-group, until hepatic progression (the time point when cross-over to the BAC-group is allowed).

  • Health economic evaluation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Health economic evaluation measured using QALY calculated using EQ5D-3L at all study visits.

  • SAE [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Number of Participants with SAE as a Measure of Safety


Estimated Enrollment: 78
Study Start Date: June 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IHP
Isolated Hepatic Perfusion
Procedure: IHP
No Intervention: BAC
Best alternative care

Detailed Description:

Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will ultimately develop in approximately 50% of the patients. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. These metastases are generally refractory to systemic chemotherapy and the median survival for patients with liver metastases is about 6 months. Regardless of treatment, the mortality rate is approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years.

Isolated hepatic perfusion (IHP) is a regional treatment that was first performed more than 40 years ago (Aust and Ausman 1960). During IHP, the liver is completely isolated from the systemic circulation, allowing a high concentration of chemotherapy to be perfused through the liver with minimal systemic exposure. In a previous study from our institution, IHP was analysed based on improvements in the procedure and the results showed an improved outcome together with minimized morbidity and mortality over time.

A phase II follow-up study confirms that IHP is a promising technique with tolerable morbidity. There are yet no randomized trials comparing overall survival in IHP, but in an attempt to answer this question the investigators did a register study showing a 14 months increased survival when comparing the patients treated with IHP with the longest surviving patients in Sweden during the same time period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged above 18 years.
  2. Signed and dated written informed consent before the start of specific protocol procedures.
  3. Histologically or cytologically proven liver metastases of uveal melanoma.
  4. Liver metastases measurable by CT/MRI (thorax and abdomen) according to RECIST version 1.1 with at least one unidimensional measurable lesion ≥ 10 mm.
  5. ECOG performance status of 0 or 1.
  6. No previous chemotherapy, radiotherapy, or biologic therapy for uveal melanoma metastases (ie first-line therapy)
  7. Adequate hepatic function (defined as ASAT,ALAT, bilirubin <= 3*ULN and PK-INR <= 1.5) and no medical history of liver cirrhosis or portal hypertension

Exclusion Criteria:

  1. More than 50% of the liver volume (measured by CT or MRI) replaced by tumour.
  2. Evidence of extrahepatic disease by PET-CT
  3. Life expectancy of less than 4 months
  4. Pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
  5. Active infection.
  6. Ischemic cardiac disease or history of congestive heart failure with an LVEF < 40%.
  7. COPD or other chronic pulmonary disease with PFT's indicating an FEV< 50% predicted for age.
  8. Reduced renal function defined as S-Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.
  9. Reduced blood leukocytes or platelets defined as LPK < 2.0x109/L and TPK <100x109/L
  10. Use of live vaccines four weeks before or after the start of study.
  11. Body mass index above 35.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785316

Contacts
Contact: Roger Olofsson, Dr +46 31 3428207 roger.olofsson@surgery.gu.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Roger Olofsson, Dr    +46 31 3428207    roger.olofsson@surgery.gu.se   
Principal Investigator: Roger Olofsson, Dr         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Roger Olofsson, Dr Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
  More Information

Publications:
Responsible Party: Roger Olofsson, Dr, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01785316     History of Changes
Other Study ID Numbers: SUGBG-013001
Study First Received: February 1, 2013
Last Updated: July 10, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

Keywords provided by Sahlgrenska University Hospital, Sweden:
Perfusion Cancer Chemotherapy, Regional

Additional relevant MeSH terms:
Eye Neoplasms
Neoplasms
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 28, 2014