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

Not Applicable

Recruiting

• Conditions: Malignant Melanoma
• Interventions: Procedure: CT or PET scans

• Registration Number: NCT03116412
• Lead Sponsor: Uppsala University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Study Start: 2017-06-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall survival	At 5 years	Measured from date of inclusion

Secondary Outcome Measures

Name	Time	Method
Quality of life/QLQ30	During the 3 year intervention period	Question of Life Questionnaire (QLQ) 30
Quality of life/HAD	During the 3 year intervention period	Hospital, Anxiety and Depression (HAD) scale

Trial Locations

Locations (20)

Södra Älvsborgs sjukhus; 🇸🇪 Boras, Sweden

Mälarsjukhuset Eskilstuna; 🇸🇪 Eskilstuna, Sweden

Falu lasarett; 🇸🇪 Falun, Sweden

Gävle sjukhus; 🇸🇪 Gavle, Sweden

Department of Surgery, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Helsingborgs lasarett; 🇸🇪 Helsingborg, Sweden

Länssjukhuset Ryhov; 🇸🇪 Jonkoping, Sweden

Länssjukhuset i Kalmar; 🇸🇪 Kalmar, Sweden

Centralsjukhuset i Karlstad; 🇸🇪 Karlstad, Sweden

Linköping University Hospital; 🇸🇪 Linkoping, Sweden

Skåne University Hospital; 🇸🇪 Malmö, Sweden

Örebro University Hospital; 🇸🇪 Orebro, Sweden

Skaraborgs sjukhus Skövde; 🇸🇪 Skovde, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Länssjukhuset Sundsvall; 🇸🇪 Sundsvall, Sweden

Uddevalla sjukhus; 🇸🇪 Uddevalla, Sweden

Umeå University Hospital; 🇸🇪 Umea, Sweden

Akademiska sjukhuset; 🇸🇪 Uppsala, Sweden

Västmanlands sjukhus Västerås; 🇸🇪 Vasteras, Sweden

Visby lasarett; 🇸🇪 Visby, Sweden