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EAGLE FM: Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial - ANZMTG 01.12

Studio Clinico

Patologia: Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

  • Must be 15 and above.
  • Have primary cutaneous melanoma or if the patient presents with stage III melanoma with no known primary tumour then a thorough search for the primary should be documented (including perineal and perianal areas)
  • Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI
  • Must have one or multiple inguinal node(s) involved, histologically or cytologically proven as metastatic melanoma. This can can be detected:
  • At the time of diagnosis;
    - Or by Ultrasound detection;
    - Or later after relapse when no Sentinel Node Biopsy (SNB) was performed at the time of primary tumour management;
    - Or as a result of SNB;
    - Or at the time of regional recurrence after 'false negative' SNB;
  • Absent distant disease clinically and on PET/CT scan. (Patients must have NO further distant disease or visceral metastases)
  • ECOG performance status must be between 0 to 2 at randomisation
  • Whole body PET/CT scan, specifically stating there is NO evidence of pelvic lymph node involvement prior to randomisation and a CT Brain or MRI Brain scan. Scans must be performed within 6 weeks prior to randomisation.
  • Able to provide written, informed consent
  • Willing to return to the centre for follow up examinations and procedures, as outlined in the protocol.
  • All patients must be randomised and undergo lymphadenectomy surgery no more than 120 days following diagnosis of inguinal LN involvement

Criteri di esclusione: 

  • Distant metastatic disease on clinical examination or staging imaging (CT/MRI brain or whole body PET/CT scan). Scans must be performed within 6 weeks prior to randomisation
  • Pelvic LN involvement on SNB or PET/CT scan suggestive of metastatic disease in the pelvis - criteria for diagnosis include normal size or enlarged lymph nodes (> 1 cm) with increased FDG activity on PET (SUV >3). If there are enlarged, necrotic lymph nodes FDG activity on PET is not required to be present. If unsure central review should be sought.
  • Bilateral inguinal lymph node involvement
  • Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past
  • Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes.
  • Unfit for General Anaesthesia
  • Melanoma-related operative procedures not corresponding to criteria described in the protocol
  • Patients with prior cancers, except:
    - those with a thin <=1 mm, regionally unrelated melanoma > 5 years ago
    - those with a good prognosis regionally unrelated cancer (>90% probability of 10 years disease specific survival)
    - other cancers diagnosed more than five years ago with no evidence of disease recurrence within this time
    - successfully treated basal cell and squamous cell skin carcinoma
    - carcinoma in-situ of the cervix
    - 1 episode of in transit melanoma > 3 years ago
  • A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
  • Positive urine pregnancy test for women of childbearing potential (+/-7 days of randomisation onto the trial)

Trattamento sperimentale: 

Inguinal Lymphadenectomy

Trattamento di controllo: 

Ilio-inguinal Lymphadenectomy

Obiettivi primari dello studio: 

  • The primary endpoint of the study will be Disease Free Survival following lymphadenectomy, assessed after 60 months of follow-up. [Time Frame: 60 Months]
    The difference between IL and I-IL surgery in DFS 5 years after randomisation

Obiettivi secondari dello studio: 

  • Overall Survival [Time Frame: 0 - 120 months]
  • Distant Disease Free Survival [Time Frame: 0 - 120 Months]
  • Regional Recurrence Free Survival [Time Frame: 0 - 120 Months]
  • Morbidity differences [Time Frame: Up to 120 days from lymphadenectomy, and from 0 - 120 months]
  • Quality Of Life [Time Frame: 0 - 120 Months]
  • Sensitivity / specificity and positive predictive value and negative predictive value of PET/CT for pelvic disease at diagnosis of groin LN involvement by melanoma. [Time Frame: 0 - 120 Months]
  • Resource use and utility based Quality Of Life [Time Frame: 0 - 60 Months]

Centri partecipanti

Nord Italia

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr. Marco Rastrelli
Telefono: 0498215594
Email: marco.rastrelli@iov.veneto.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT02166788

Data di inserimento: 11.04.2019

Promotore

Australia and New Zealand Melanoma Trials Group

CRO

/

Principal Investigator ITALIA

IOV - Istituto Oncologico Veneto IRCCS (Padova)

Riferimento: Dr. Marco Rastrelli

Telefono: 0498215594

Email: marco.rastrelli@iov.veneto.it

Localita: Padova

 

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