NODE (groiN ultrasOunD cancEr)

Launched by QUEENSLAND CENTRE FOR GYNAECOLOGICAL CANCER · Feb 8, 2024

Keywords

ClinConnect Summary

The NODE clinical trial is studying two different treatment options for women with early-stage vulvar cancer. The main goal is to find out if it is possible to randomly assign patients to either have surgery to remove lymph nodes in the groin or to have regular check-ups with high-resolution ultrasounds every two months to monitor their condition. This is important because it could help doctors understand which approach is better for managing the cancer and its potential spread.

To be eligible for this trial, women must be over 18 and have a confirmed diagnosis of vulvar cancer at stages I or II, meaning the cancer is still relatively small and has not spread significantly. Participants should also be able to undergo the surgical procedure according to medical guidelines. Anyone interested in joining the trial can expect close monitoring and care throughout the study, as well as the chance to contribute to important research that could improve treatment options for vulvar cancer patients in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women, over 18 years, with histologically confirmed SCC, adenocarcinoma or melanoma of the vulva
• • Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
• • Participant must be suitable to undergo IFL/SNB according to local clinical practice management guidelines
• • Signed written informed consent
• • Negative serum pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause
• • Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances)
• Exclusion Criteria:
• • Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
• • Squamous cell carcinoma (SCC) of the vulva with depth of invasion ≤1 mm
• • Clinical or medical imaging evidence of regional and/or distant metastatic disease
• • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
• • Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ
• • Estimated life expectancy of ≤6 months