A Randomized Trial to Assess the Role of Imaging During Follow up After Radical Surgery of High Risk Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized Multicenter Trial to Assess the Role of Imaging During Follow up After Radical Surgery of Stage IIb-c and III Cutaneous Malignant Melanoma

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Procedure: CT or PET scans


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine follow up<br>Follow up according to national guidelines. | |
| Experimental: Radiological assessments<br>Radiological assessments (CT or PET scans) at 5 occasions during 3 years. | Procedure: CT or PET scans<br>* Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Measured from date of inclusion | At 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life/QLQ30 | Question of Life Questionnaire (QLQ) 30 | During the 3 year intervention period | 
| Quality of life/HAD | Hospital, Anxiety and Depression (HAD) scale | During the 3 year intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant melanoma, Follow up, Radiology, Survival