The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01785316
Recruitment Status : Recruiting
First Posted : February 7, 2013
Last Update Posted : April 25, 2017
Karolinska University Hospital
University Hospital, Linkoeping
Uppsala University Hospital
Skane University Hospital
University Hospital, Umeå
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Roger Olofsson, Sahlgrenska University Hospital, Sweden

Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma Uveal Neoplasms Procedure: IHP Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases
Study Start Date : June 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: IHP
Isolated Hepatic Perfusion
Procedure: IHP
No Intervention: BAC
Best alternative care

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    OS defined as the frequency of individuals alive at 24 months

Secondary Outcome Measures :
  1. Hepatic progression-free survival [ Time Frame: 24 months ]
    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.

  2. Response [ Time Frame: 24 months ]
    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).

  3. Health economic evaluation [ Time Frame: 24 months ]
    Health economic evaluation measured using QALY calculated using EQ5D-3L at all study visits.

  4. SAE [ Time Frame: 24 months ]
    Number of Participants with SAE as a Measure of Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. If this is not possible at the time of randomization, a biopsy is mandatory before start of treatment.
  4. Liver metastases measurable by MRI (preferred) or CT of thorax and abdomen according to RECIST version 1.1 with at least one unidimensional measurable lesion ≥ 10 mm. The examination should be within 4 weeks prior to randomization.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01785316

Contact: Roger Olofsson Bagge, Dr +46 31 3428207

Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Roger Olofsson, Dr    +46 31 3428207   
Principal Investigator: Roger Olofsson, Dr         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
University Hospital, Linkoeping
Uppsala University Hospital
Skane University Hospital
University Hospital, Umeå
Rigshospitalet, Denmark
Principal Investigator: Roger Olofsson Bagge, Dr Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Roger Olofsson, Dr, Sahlgrenska University Hospital, Sweden Identifier: NCT01785316     History of Changes
Other Study ID Numbers: SUGBG-013001
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Eye Neoplasms
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