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

NCT01785316 | Completed Phase 3 DMC

• 1 other identifier: SUGBG-013001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Uveal Neoplasms

Keywords

Perfusion Cancer Chemotherapy, Regional

Outcome Measures

Primary Outcomes (1)

• Overall survival

  OS defined as the frequency of individuals alive at 24 months

  24 months

Secondary Outcomes (4)

• Hepatic progression-free survival

  24 months

• Response

  24 months

• Health economic evaluation

  24 months

• SAE

  24 months

Study Arms (2)

IHP

EXPERIMENTAL

Isolated Hepatic Perfusion

Procedure: IHP

BAC

NO INTERVENTION

Best alternative care

Interventions

IHP PROCEDURE

IHP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Karolinska University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Uppsala University Hospital: collaborator
• Skane University Hospital: collaborator
• University Hospital, Umeå: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (4)

• 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.

  PMID: 18337648 BACKGROUND

• 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.

  PMID: 24141377 BACKGROUND

• 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.

  PMID: 36940407 RESULT

• 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.

  PMID: 25106493 DERIVED

MeSH Terms

Conditions

Melanoma; Uveal Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Eye Neoplasms; Eye Diseases; Uveal Diseases

Study Officials

• Roger Olofsson Bagge, Dr

  Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: June 15, 2013
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

SE (1)