None listed
Conditions
Brief summary
This study aims to determine optimum surgical management of patients with melanoma spread to their groin lymph nodes. Who is it for? You may be eligible to join this study if you are aged 15 years or above and have been diagnosed with primary cutaneous melanoma or stage III melanoma with metastases (i.e. tumour spread) in the groin area. Study details Participants in this study will be randomly (by chance) allocated to one of two surgery types. Participants in one group will be undergo Inguinal Lymphadenectomy (IL), which is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11. Participants in the other group will undergo Ilio-inguinal Lymphadenectomy (I-IL) which involves removal of the same superficial groin LNs but also combined with the more surgically complex removal of the ipsilateral pelvic LN. About twice as many LN are removed with I-IL compared to IL. Currently surgeons have polarized opinions as to whether to perform a limited or more extensive lymphadenectomy and there is no evidence of which is the best option. Participants will be followed-up for a period of up to 10 years in order to evaluate disease response, survival and quality of life outcomes. The results of this study may standardise care globally, lead to better cancer outcomes, reduce surgical morbidity and reduce economic burden for the health sector.
Interventions
Inguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 whereas with Ilio-inguinal Lymphadenectomy (I-IL) there is removal of the same superficial groin LNs but also combined with the more surgically complex removal of the ipsilateral pelvic LN. About twice as many LN are removed with I-IL compared to IL. The approximate duration of both procedures is 3 hours.
Arm 1: Inguinal Lymphadenectomy
Arm 2: Ilio-inguinal L
Inguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 whereas with Ilio-inguinal Lymphadenectomy (I-IL) there is removal of the same superficial groin LNs but also combined with the more surgically complex removal of the ipsilateral pelvic LN. About twice as many LN are removed with I-IL compared to IL. The approximate duration of both procedures is 3 hours. Arm 1: Inguinal Lymphadenectomy Arm 2: Ilio-inguinal Lymphadenectomy
Sponsors
Melanoma and Skin Cancer Trial
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients may be included in the study only if they meet all of the following criteria: 1. Must be 15 and above. 2. 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) 3. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI 4. Must have one or multiple inguinal node(s) involved, histologically or cytologically proven as metastatic melanoma. This can can be detected: a. At the time of diagnosis; b. Or by Ultrasound detection; c. Or later after relapse when no Sentinel Node Biopsy (SNB) was performed at the time of primary tumour management; d. Or as a result of SNB; e. Or at the time of regional recurrence after “false negative” SNB; f. Absent distant disease clinically and on PET/CT scan. (Patients must have NO further distant disease or visceral metastases) 6. ECOG performance status must be between 0 to 2 at randomisation 7. 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. 8. Able to provide written, informed consent 9. Willing to return to the centre for follow up examinations and procedures, as outlined in the protocol. 10. All patients must be randomised and undergo lymphadenectomy surgery no more than 120 days following diagnosis of inguinal LN involvement
Exclusion criteria
Patients will be excluded from the study for any of the following reasons: 1. 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 2. 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. 3. Bilateral inguinal lymph node involvement 4. Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past 5. Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes. 6. Unfit for General Anaesthesia 7. Melanoma-related operative procedures not corresponding to criteria described in the protocol 8. Patients with prior cancers, except: a. those with a thin <=1 mm, regionally unrelated melanoma > 5 years ago b. Those with a good prognosis regionally unrelated cancer (>90% probability of 10 years disease specific survival) c. Other cancers diagnosed more than five years ago with no evidence of disease recurrence within this time d. Successfully treated basal cell and squamous cell skin carcinoma e. Carcinoma in-situ of the cervix f. 1 episode of in transit melanoma > 3 years ago 9. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol 10. Positive urine pregnancy test for women of childbearing potential (+/-7 days of randomisation onto the trial)
Outcome results
None listed