Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP
Brief Summary:
Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival are influenced by metastatic lymph node involvement. Its frequency in France is estimated at less than 1% of human cancers. This spread follows a sequential process via the superficial and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic dissemination.
The management of inguinal areas is the cornerstone of penile cancer. It is curative in about 80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on average 85% for pN0 patients and 40% for pN + patients. For pN + patients, 5-years overall survival was 70 to 80% for pN1 (only 1 lymph node invasion), and 30 to 40% for pN2 and 0 to 10% for pN3.
The risk of local recurrence is 5-10% for pN0 and 20-30% for pN + after local treatment by lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months. Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN +. Its indication depends on clinical examination (presence or absence of lymph nodes palpated) and the risk of nodal disease (≥ pT1bG2).
Currently, a fine needle biopsy is the best clinical diagnosis method because it is a simple, low risk and possible in consultation. When the result is positive, it allows an early dissection. Single or double fine needle biopsy will be used in cN + patients. For patients at risk of lymp nodes involvement (cN0 and ≥ pT1B or G2), the sentinel node diagnosis may be followed by modified or bilateral lymphadenectomy.
Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in patients with metastatic lymph node involvement. Therefore it seems important to develop a multimoda