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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура CT or PET scans
  Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

Первичные конечные точки

• Overall survival [Срок оценки: At 5 years]

Вторичные конечные точки (2)

• Quality of life/QLQ30 [Срок оценки: During the 3 year intervention period]
• Quality of life/HAD [Срок оценки: During the 3 year intervention period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Швеция · 20 центров

• 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
• … и ещё 12 центров

Публикации

• 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

Идентификаторы

NCT: NCT03116412 · TRIM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗