A Prospective randomised trial of sentinel node biopsy for high risk non-melanoma skin cancer.

A phase III Multicenter Randomised Trial in High Risk Non Melanoma Skin Cancer of Sentinel Lymph Node Biopsy and Lymphadenectomy versus Nodal Observation on Disease Free and Overall Survival.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000713998

Acronym

SNIC trial

Enrollment

300

Registered

2011-07-11

Start date

2012-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine the effect of sentinel lymph node biopsy on survival in people with high risk non melanoma skin cancer. Who is it for? You can join this study if you are aged 18 years or more, have high risk non melanoma skin cancer, and will be available for a 5 year follow-up assessment. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Both groups will undergo removal of their skin cancer. In addition, participants in one group will receive sentinel lymph node biopsy. This is a procedure in which the local lymph node ("gland") that drain the patch of skin containing the tumour are excised. These lymph node(s) are examined under a microscope to determine whether cancer cells are present. If cancer cells are found, patients will undergo completion lymphadenectomy (i.e. surgical removal of the rest of the regional lymph nodes). Participants in the second group will undergo observation of regional lymph nodes, and those that develop cancer cells will undergo completion lymphadenectomy. All patients will undergo continued observation for a period of 5 years to determine survival and quality of life.

Interventions

Wide local excision of the primary site and Sentinel lymph node biopsy (SLNB) with completion lymphadenectomy (second procedure at later date) for histopathologically positive sentinel nodes. Both sentinel node positive and sentinel node negative patients will receive 5 years follow up and continuing observation of lymphatic basin for metastasis.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants must be able to give fully informed consent and have non melanoma skin cancer with any of the following clinicopathologic risk factors: -size > 2cm -invasion into subcutaneous fat or tumour thickness > 5mm -poorly differentiated phenotype -perineural invasion -lymphovascular invasion -local recurrence -location of lesion on lip or ear -immunocomprimised host (post organ transplant, chemotherapy) -carcinoma developing in pre-existing scar

Exclusion criteria

Subjects meeting any of the following criteria will be excluded from participation: -Clinical evidence of distant metastases -previous surgery that is believed to have altered the local lymphatic drainage since emergence of lesion -allergy to patent blue dye or radiocolloid -significant cognitive or psychiatric disorder (inability to understand informed consent) -pregnancy/lactation -inability to complete 5 years of follow up -Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.

Outcome results