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 cutaneous malignant Melanoma

Ylva Naeser, Hildur Helgadottir, Yvonne Brandberg, Johan Hansson, Roger Olofsson Bagge, Nils O Elander, Christian Ingvar, Karolin Isaksson, Petra Flygare, Cecilia Nilsson, Frida Jakobsson, Olga Del Val Munoz, Antonis Valachis, Malin Jansson, Charlotte Sparring, Lars Ohlsson, Ulf Dyrke, Dimitrios Papantoniou, Anders Sundin, Gustav J Ullenhag, Ylva Naeser, Hildur Helgadottir, Yvonne Brandberg, Johan Hansson, Roger Olofsson Bagge, Nils O Elander, Christian Ingvar, Karolin Isaksson, Petra Flygare, Cecilia Nilsson, Frida Jakobsson, Olga Del Val Munoz, Antonis Valachis, Malin Jansson, Charlotte Sparring, Lars Ohlsson, Ulf Dyrke, Dimitrios Papantoniou, Anders Sundin, Gustav J Ullenhag

Abstract

Background: The incidence of cutaneous malignant melanoma (CMM) is increasing worldwide. In Sweden, over 4600 cases were diagnosed in 2018. The prognosis after radical surgery varies considerably with tumor stage. In recent years, new treatment options have become available for metastatic CMM. Early onset of treatment seems to improve outcome, which suggests that early detection of recurrent disease should be beneficial. Consequently, in several countries imaging is a part of the routine follow-up program after surgery of high risk CMM. However, imaging has drawbacks, including resources required (costs, personnel, equipment) and the radiation exposure. Furthermore, many patients experience anxiety in waiting for the imaging results and investigations of irrelevant findings is another factor that also could cause worry and lead to decreased quality of life. Hence, the impact of imaging in this setting is important to address and no randomized study has previously been conducted. The Swedish national guidelines stipulate follow-up for 3 years by clinical examinations only.

Methods: The TRIM study is a prospective randomized multicenter trial evaluating the potential benefit of imaging and blood tests during follow-up after radical surgery for high-risk CMM, compared to clinical examinations only. Primary endpoint is overall survival (OS) at 5 years. Secondary endpoints are survival from diagnosis of relapse and health-related quality of life (HRQoL). Eligible for inclusion are patients radically operated for CMM stage IIB-C or III with sufficient renal function for iv contrast-enhanced CT and who are expected to be fit for treatment in case of recurrence. The planned number of patients is > 1300. Patients are randomized to clinical examinations for 3 years +/- whole-body imaging with CT or FDG-PET/CT and laboratory tests including S100B protein and LDH. This academic study is supported by the Swedish Melanoma Study Group.

Discussion: This is the first randomized prospective trial on the potential benefit of imaging as a part of the follow-up scheme after radical surgery for high-risk CMM.

Results: The first patient was recruited in June 2017 and as of April 2020, almost 500 patients had been included at 19 centers in Sweden.

Trial registration: ClinicalTrials.gov , NCT03116412 . Registered 17 April 2017, https://ichgcp.net/clinical-trials-registry/NCT03116412.

Keywords: CT; Cutaneous malignant melanoma; FDG-PET/CT; Follow-up.

Conflict of interest statement

None declared.

Figures

Fig. 1
Fig. 1
Overall trial design
Fig. 2
Fig. 2
Recruitment status for individual centers. Striped bars represent university hospitals. Oncology sites are marked with a star (*)

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