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

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ClinicalTrials.gov Identifier: NCT01785316
Recruitment Status : Recruiting
First Posted : February 7, 2013
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Karolinska University Hospital
University Hospital, Linkoeping
Uppsala University Hospital
Skane University Hospital
University Hospital, Umeå
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden

February 1, 2013
February 7, 2013
July 13, 2018
June 2013
December 2019   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: 24 months ]
OS defined as the frequency of individuals alive at 24 months
Same as current
Complete list of historical versions of study NCT01785316 on ClinicalTrials.gov Archive Site
  • 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.
  • 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).
  • Health economic evaluation [ Time Frame: 24 months ]
    Health economic evaluation measured using QALY calculated using EQ5D-3L at all study visits.
  • SAE [ Time Frame: 24 months ]
    Number of Participants with SAE as a Measure of Safety
Same as current
Not Provided
Not Provided
 
The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases
The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma
  • Uveal Neoplasms
Procedure: IHP
  • Experimental: IHP
    Isolated Hepatic Perfusion
    Intervention: Procedure: IHP
  • No Intervention: BAC
    Best alternative care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
78
December 2021
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Roger Olofsson Bagge, Dr +46 31 3428207 roger.olofsson.bagge@gu.se
Sweden
 
 
NCT01785316
SUGBG-013001
Yes
Not Provided
Not Provided
Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden
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
Sahlgrenska University Hospital, Sweden
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP