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

Primary Purpose

Melanoma, Uveal Neoplasms

Status

Completed

Phase

Phase 3

Locations

Sweden

Study Type

Interventional

Intervention

IHP

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Perfusion Cancer Chemotherapy, Regional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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%.
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.

Sites / Locations

Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IHP

BAC

Arm Description

Isolated Hepatic Perfusion

Best alternative care

Outcomes

Primary Outcome Measures

Overall survival

OS defined as the frequency of individuals alive at 24 months

Secondary Outcome Measures

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.

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).

Health economic evaluation

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

SAE

Number of Participants with SAE as a Measure of Safety

Full Information

NCT ID

NCT01785316

First Posted

February 1, 2013

Last Updated

April 3, 2023

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Karolinska University Hospital, University Hospital, Linkoeping, Uppsala University Hospital, Skane University Hospital, University Hospital, Umeå, Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01785316

Brief Title

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

Acronym

SCANDIUM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 15, 2013 (Actual)

Primary Completion Date

March 15, 2023 (Actual)

Study Completion Date

March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Karolinska University Hospital, University Hospital, Linkoeping, Uppsala University Hospital, Skane University Hospital, University Hospital, Umeå, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Uveal Neoplasms

Keywords

Perfusion Cancer Chemotherapy, Regional

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IHP

Arm Type

Experimental

Arm Description

Isolated Hepatic Perfusion

Arm Title

BAC

Arm Type

No Intervention

Arm Description

Best alternative care

Intervention Type

Procedure

Intervention Name(s)

IHP

Primary Outcome Measure Information:

Title

Overall survival

Description

OS defined as the frequency of individuals alive at 24 months

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Hepatic progression-free survival

Description

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.

Time Frame

24 months

Title

Response

Description

Time Frame

24 months

Title

Health economic evaluation

Description

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

Time Frame

24 months

Title

SAE

Description

Number of Participants with SAE as a Measure of Safety

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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%. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger Olofsson Bagge, Dr

Organizational Affiliation

Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sahlgrenska University Hospital

City

Gothenburg

ZIP/Postal Code

413 45

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

18337648

Citation

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.

Results Reference

background

PubMed Identifier

24141377

Citation

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.

Results Reference

background

PubMed Identifier

36940407

Citation

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.

Results Reference

result

PubMed Identifier

25106493

Citation

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. Erratum In: Trials. 2015;16:334. All-Ericsson, Charlotta [Added].

Results Reference

derived

Links:

URL

http://www.scandiumtrial.se

Description

Scandium Trial webpage

Learn more about this trial

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

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