Informations générales (source: ClinicalTrials.gov)
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 (MEGACEP)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
octobre 2016
septembre 2028
05 décembre 2024
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+).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Christine ABRAHAM | 28/04/2025 15:59:46 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre FRANCOIS BACLESSE - 14076 - Caen - France | Florence JOLY, Prof | Contact (sur clinicalTrials) | |||
| Ch de Limoges - 87042 - Limoges - France | Aurélien DESCAZEAUD, Professor | Contact (sur clinicalTrials) | |||
| Chr Besancon - 25000 - Besançon - France | Tristant MAURINA, Doctor | Contact (sur clinicalTrials) | |||
| Clinique Urologique- Chu Hotel Dieu - 44093 - Nantes - France | Jérôme RIGAUD, Professor | Contact (sur clinicalTrials) | |||
| Hôpital SAINT ANDRE - 33075 - Bordeaux - France | Amaury DASTE, Doctor | Contact (sur clinicalTrials) | |||
| Hopitaux Universitaires de Strasbourg - 67091 - Strasbourg - France | Philippe BARTHELEMY, Doctor | Contact (sur clinicalTrials) | |||
| ICO-Paul Papin - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| ICO-René Gauducheau - 44805 - saint Herblain - France | Emmanuelle BOMPAS, Doctor | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Lorraine - 54519 - Nancy - France | Vincent MASSARD, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie Du Gard - Centre Oncogard - 300029 - Nîmes - France | Angélique CHAPELLE, Doctor | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon - France | Aude FLECHON, Doctor | Contact (sur clinicalTrials) | |||
| Chu de Rouen - 76031 - Rouen - France | Christian PFISTER, Professor | Contact (sur clinicalTrials) | |||
| Chu Lyon Sud - 69310 - Lyon - France | Jean-Etienne TERRIER, Dr | Contact (sur clinicalTrials) | |||
| Hopital Saint Louis - 75010 - Paris - France | Stéphane CULINE, Professor | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - France | Gwenaelle GRAVIS, Doctor | Contact (sur clinicalTrials) | |||
Critères
Homme
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.
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.
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.