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Evaluation of Lymphadenectomy and Chemotherapy TIP on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis
Sponsor: UNICANCER
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-year overall survival was 70 to 80% for pN1 (only 1 lymph node invasion), 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 multimodal approach in the management of these patients in order to increase the response rate to treatment and survival. From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide, and cisplatin) appears to have an efficacy / toxicity acceptable. The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant treatment in patients with high risk of lymph nodes involvement (cN0 and ≥pT1B or G2), and with inguinal mobile palpated lymph nodes (cN+) respectively, after lymph nodes involvement proven (pN+).
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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2016-10-17
Completion Date
2028-09
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
Chemotherapy TIP
Paclitaxel, ifosfamide, and cisplatin
Locations (17)
ICO-Paul Papin
Angers, France
Chr Besancon
Besançon, France
Hôpital SAINT ANDRE
Bordeaux, France
Centre FRANCOIS BACLESSE
Caen, France
Chru Gabriel Montpied
Clermont-Ferrand, France
Ch de Limoges
Limoges, France
Centre Leon Berard
Lyon, France
Chu Lyon Sud
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Institut de Cancerologie de Lorraine
Nancy, France
Clinique Urologique- Chu Hotel Dieu
Nantes, France
Institut de Cancerologie Du Gard - Centre Oncogard
Nîmes, France
Hopital Saint Louis
Paris, France
Chu de Rouen
Rouen, France
ICO-René Gauducheau
Saint-Herblain, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Institut Claudius Regaud
Toulouse, France