Clinical trial NCT03116412: A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Melanoma
Keywords: Malignant melanoma
Follow up
Radiology
Survival
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: At 5 years
Secondary outcomes:
measure: Quality of life/QLQ30
timeFrame: During the 3 year intervention period
measure: Quality of life/HAD
timeFrame: During the 3 year intervention period
Other outcomes:
measure: Disease free survival (DFS)
timeFrame: 3 years
Locations:
city: Boras
country: Sweden
facility: Södra Älvsborgs sjukhus
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset Eskilstuna
city: Falun
country: Sweden
facility: Falu lasarett
city: Gavle
country: Sweden
facility: Gävle sjukhus
city: Gothenburg
country: Sweden
facility: Department of Surgery, Sahlgrenska University Hospital
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Jonkoping
country: Sweden
facility: Länssjukhuset Ryhov
city: Kalmar
country: Sweden
facility: Länssjukhuset i Kalmar
city: Karlstad
country: Sweden
facility: Centralsjukhuset i Karlstad
city: Linkoping
country: Sweden
facility: Linköping University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Orebro
country: Sweden
facility: Örebro University Hospital
city: Skovde
country: Sweden
facility: Skaraborgs sjukhus Skövde
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Sundsvall
country: Sweden
facility: Länssjukhuset Sundsvall
city: Uddevalla
country: Sweden
facility: Uddevalla sjukhus
city: Umea
country: Sweden
facility: Umeå University Hospital
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Vasteras
country: Sweden
facility: Västmanlands sjukhus Västerås
city: Visby
country: Sweden
facility: Visby lasarett
Study officials:
affiliation: Uppsala University Hospital
name: Gustav Ullenhag, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 cutaneous malignant Melanoma. BMC Cancer. 2020 Dec 7;20(1):1197. doi: 10.1186/s12885-020-07632-4.