A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma (TRIM)

Uppsala University

Status: Enrolling

Conditions: Malignant Melanoma

Treatments: Procedure: CT or PET scans

Study type: Interventional

Funder types: Other

Identifiers

NCT03116412

TRIM

Details and patient eligibility

About

It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.

Full description

The patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body CT or Positron Emission Tomography (PET) scans and blood tests. An interim analysis will be conducted when 1000 patients have been included.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age.
• Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.
• Sufficient renal function for i.v. contrast scannings.

Exclusion criteria

• The patient is assessed as unfit to receive treatment in the case of recurrence.
• Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).
• Inability to provide informed consent or refusal to do so.
• Inability to comply with the control or intense follow-up program.
• Participation in other clinical trials interfering with the control-program.
• Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).
• Pregnancy or currently planned pregnancy.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

Routine follow up

No Intervention group

Description:

Follow up according to national guidelines.

Radiological assessments

Experimental group

Description:

Radiological assessments (CT or PET scans) at 5 occasions during 3 years.

Treatment:

Procedure: CT or PET scans