A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT or PET scans.
- Who it may be relevant to
- Registry conditions: Malignant Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Procedure CT or PET scans
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
Primary outcome measures
- Overall survival [Time frame: At 5 years]
Secondary outcome measures (2)
- Quality of life/QLQ30 [Time frame: During the 3 year intervention period]
- Quality of life/HAD [Time frame: During the 3 year intervention period]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Sweden · 20 centers
- Södra Älvsborgs sjukhus — Borås
- Mälarsjukhuset Eskilstuna — Eskilstuna
- Falu lasarett — Falun
- Gävle sjukhus — Gävle
- Department of Surgery, Sahlgrenska University Hospital — Gothenburg
- Helsingborgs lasarett — Helsingborg
- Länssjukhuset Ryhov — Jönköping
- Länssjukhuset i Kalmar — Kalmar
- … and 12 more centers
Publications
- Ladjevardi CO, Naeser Y, Dyrke U, Papantoniou D, Bagge RO, Elander N, Ingvar C, Flygare P, Nilsson C, Jakobsson F, Lange-Norstrom K, Sundin A, Berglund A, Nyberg F, Ahringberg-Kald B, Helgadottir H, Ullenhag G. Physical examinations and whole-body imaging versus physical examinations alone during follow-up after radical surgery of stage IIB-C and III cutaneous malignant melanoma (TRIM): an interim PMID 41167217
- Naeser Y, Helgadottir H, Brandberg Y, Hansson J, Bagge RO, Elander NO, Ingvar C, Isaksson K, Flygare P, Nilsson C, Jakobsson F, Del Val Munoz O, Valachis A, Jansson M, Sparring C, Ohlsson L, Dyrke U, Papantoniou D, Sundin A, Ullenhag GJ. TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutan PMID 33287744
Identifiers
NCT: NCT03116412 · TRIM