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MelanomaPhase 3SCANDIUMNCT01785316

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

A Phase 3 study testing IHP in people with Melanoma and Uveal Neoplasms, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Uveal Neoplasms
What is being tested?
IHP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteSweden
Study dates
15 Jun 2013to 15 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged above 18 years.
  • Signed and dated written informed consent before the start of specific protocol procedures.
  • 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.
  • 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.
  • ECOG performance status of 0 or 1.
  • No previous chemotherapy, radiotherapy, or biologic therapy for uveal melanoma metastases (ie first-line therapy)
  • 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

Who cannot join

  • More than 50% of the liver volume (measured by CT or MRI) replaced by tumour.
  • Evidence of extrahepatic disease by PET-CT
  • Life expectancy of less than 4 months
  • Pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
  • Active infection.
  • Ischemic cardiac disease or history of congestive heart failure with an LVEF < 40%.
Show all 11Show fewer
  • COPD or other chronic pulmonary disease with PFT's indicating an FEV< 50% predicted for age.
  • Reduced renal function defined as S-Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.
  • Reduced blood leukocytes or platelets defined as LPK < 2.0x109/L and TPK <100x109/L
  • Use of live vaccines four weeks before or after the start of study.
  • Body mass index above 35.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
IHP
Keywords
Perfusion Cancer Chemotherapy, Regional
Medical subject headings
Melanoma, Uveal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IHPProcedure or surgery

Study groups in NCT01785316
Study groupRoleWhat they receive
IHPExperimentalIsolated Hepatic Perfusion
Receives: Procedure: IHP
BACNo interventionBest alternative care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    OS defined as the frequency of individuals alive at 24 months

    Measured: 24 months

Secondary outcomes (4)

  1. Hepatic progression-free survival

    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.

    Measured: 24 months

  2. Response

    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).

    Measured: 24 months

  3. Health economic evaluation

    Health economic evaluation measured using QALY calculated using EQ5D-3L at all study visits.

    Measured: 24 months

  4. SAE

    Number of Participants with SAE as a Measure of Safety

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2013 (estimated)
  2. Study start15 Jun 2013
  3. Primary completion15 Mar 2023
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01785316
Sponsor's protocol ID
SUGBG-013001
Acronym
SCANDIUM
Status last verified
Jan 2024
First submitted
1 Feb 2013
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Rizell M, Mattson J, Cahlin C, Hafstrom L, Lindner P, Olausson M. Isolated hepatic perfusion for liver metastases of malignant melanoma. Melanoma Res. 2008 Apr;18(2):120-6. doi: 10.1097/CMR.0b013e3282f8e3c9.

    PubMed 18337648

  • Olofsson R, Cahlin C, All-Ericsson C, Hashimi F, Mattsson J, Rizell M, Lindner P. Isolated hepatic perfusion for ocular melanoma metastasis: registry data suggests a survival benefit. Ann Surg Oncol. 2014 Feb;21(2):466-72. doi: 10.1245/s10434-013-3304-z. Epub 2013 Oct 19.

    PubMed 24141377

  • Olofsson Bagge R, Nelson A, Shafazand A, All-Eriksson C, Cahlin C, Elander N, Helgadottir H, Kiilgaard JF, Kinhult S, Ljuslinder I, Mattsson J, Rizell M, Sternby Eilard M, Ullenhag GJ, Nilsson JA, Ny L, Lindner P. Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases: A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial). J Clin Oncol. 2023 Jun 1;41(16):3042-3050. doi: 10.1200/JCO.22.01705. Epub 2023 Mar 20.

    PubMed 36940407

  • Olofsson R, Ny L, Eilard MS, Rizell M, Cahlin C, Stierner U, Lonn U, Hansson J, Ljuslinder I, Lundgren L, Ullenhag G, Kiilgaard JF, Nilsson J, Lindner P. Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial. Trials. 2014 Aug 9;15:317. doi: 10.1186/1745-6215-15-317.

    PubMed 25106493

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IHP in people with Melanoma and Uveal Neoplasms, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01785316, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

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