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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CT or PET scans

    Procedure/Surgery

    Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: Routine follow upNo intervention 0 interventions
Group B: Radiological assessmentsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Measured from date of inclusion

Time frame
At 5 years

Secondary outcomes

1

Quality of life/QLQ30

Question of Life Questionnaire (QLQ) 30

Time frame
During the 3 year intervention period
2

Quality of life/HAD

Hospital, Anxiety and Depression (HAD) scale

Time frame
During the 3 year intervention period

Other outcomes

1

Disease free survival (DFS)

Time frame
3 years

Sponsors and contacts

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