Evaluating lymph node surgery and chemotherapy for penile cancer

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

This study is testing if surgery to remove lymph nodes along with chemotherapy can help men with penile cancer live longer and reduce the chance of the cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Unicancer (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Angers and 16 other locations)
• Trial ID: NCT02817958 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients with squamous cell carcinoma of the penis, particularly those with inguinal lymph node involvement. It aims to assess the effectiveness of lymphadenectomy combined with TIP chemotherapy in improving survival outcomes. The study includes patients with varying stages of lymph node involvement and evaluates their response to the treatment. The goal is to enhance disease-free survival rates and reduce the risk of local recurrence in affected individuals.

Who should consider this trial

Good fit: Ideal candidates include adult males with histologically confirmed penile tumors and specific lymph node involvement.

Not a fit: Patients with advanced metastatic disease beyond the lymph nodes or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with penile cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing lymph node involvement in various cancers, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) \<2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) \>50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss \>Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

Where this trial is running

Angers and 16 other locations

• ICO-Paul Papin — Angers, France (Terminated)
• Chr Besancon — Besançon, France (Recruiting)
• Hôpital SAINT ANDRE — Bordeaux, France (Recruiting)
• Centre FRANCOIS BACLESSE — Caen, France (Recruiting)
• Chru Gabriel Montpied — Clermont Ferrand, France (Recruiting)
• Ch de Limoges — Limoges, France (Recruiting)
• Centre Leon Berard — Lyon, France (Recruiting)
• Chu Lyon Sud — Lyon, France (Recruiting)
• Institut Paoli-Calmettes — Marseille, France (Recruiting)
• Institut de Cancerologie de Lorraine — Nancy, France (Recruiting)
• Clinique Urologique- Chu Hotel Dieu — Nantes, France (Recruiting)
• Institut de Cancerologie Du Gard - Centre Oncogard — Nîmes, France (Recruiting)
• Hopital Saint Louis — Paris, France (Recruiting)
• Chu de Rouen — Rouen, France (Recruiting)
• ICO-René Gauducheau — saint Herblain, France (Recruiting)
• Hopitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
• Institut Claudius Regaud — Toulouse, France (Terminated)

Study contacts

• Principal investigator: Jérôme Rigaud, Professor — Nantes University Hospital
• Study coordinator: Vanessa SCHARTNER

Conditions Penile Cancer; Squamous Carcinoma; inguinal lymph nodes; penile cancer; squamous; TIP chemotherapy