Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma

Korábbi kezelés

• 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
• Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes.

Más betegség

• 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.
• Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past
• A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol

Életkor

• 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

Egyéb

• Bilateral inguinal lymph node involvement
• Unfit for General Anaesthesia
• Melanoma-related operative procedures not corresponding to criteria described in the protocol
• Positive urine pregnancy test for women of childbearing potential (+/-7 days of randomisation onto the trial)

• Patients may be included in the study only if they meet all of the following criteria:
• 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