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

  • STATUS
    Recruiting
  • End date
    Sep 3, 2024
  • participants needed
    37
  • sponsor
    UNICANCER
Updated on 23 February 2022
paclitaxel
cancer
squamous cell carcinoma
metastasis
chemotherapy regimen
immunomodulator

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+).

Details
Condition Penile Cancer, Squamous Carcinoma
Treatment Chemotherapie TIP, Chemotherapy TIP
Clinical Study IdentifierNCT02817958
SponsorUNICANCER
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy
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
Metastatic lymph node involvement
Patients M0 or Mx
Age 18 ans
Eastern Cooperative Oncology Group (ECOG) 0-1
Leucocytes 1.5 g/L
Hemoglobin 9 g/dL
Platelets 100 000/mm
Normal calcemia and kaliemia
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
Creatinine clearance 60 mL/min (MDRD method)
Left ventricular ejection fraction (LVEF) >50%
Patients having received, read the information note and signed consent
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
Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol)
Patients undergoing a social security scheme

Exclusion Criteria

Fixed inguinal lymph nodes (cN3)
Iliac lymph nodes (cN3)
Patients pN3
prior chemotherapy for squamous cell carcinoma of the penis
Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel
Patients treated with phenytoin
Patients with hearing loss >Grade 1 (CTCAE V4.03)
Patients with cardiopulmonary disease-indicating against overhydration
History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell
Patient received a live attenuated vaccine within 30 days prior to inclusion
Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial
Patients deprived of their liberty or under court protection including guardianship
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
immunocompromised patients including with known seropositivity (HIV)
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
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