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ACTIVE NOT RECRUITING
NCT02817958
PHASE2

Evaluation of Lymphadenectomy and Chemotherapy TIP on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis

Sponsor: UNICANCER

View on ClinicalTrials.gov

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

Interventions

DRUG

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