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NCT Number: NCT02817958

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

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+).

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Key information

Conditions

Penile Cancer Carcinoma Carcinoma, Squamous Cell Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Penile Diseases Penile Neoplasms Squamous Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

ICO-Paul Papin, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/mm³,
  • 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.

Treatment and study plan

Chemotherapy TIP

Drug

Paclitaxel, ifosfamide, and cisplatin

Other names: Chemotherapy TIP (paclitaxel, ifosfamide et cisplatine)

Primary outcomes

  1. survival without locoregional lymph node recurrence

    Time frame: 24 months

    checked by inguinal ultrasound

Secondary outcomes

  1. Complete response rate for patients in neoadjuvant chemotherapy

    Time frame: 6 months

    lack of residual tumor post surgical histopathology

  2. Survival without locoregional lymph node recurrence

    Time frame: 3 years

    time between inclusion and locoregional recurrence or last evaluation

  3. Survival without metastasis

    Time frame: 3 years

    time between inclusion and the date of occurrence of metastases

  4. Specific survival

    Time frame: 3 years

    time between inclusion and date of death from penile cancer or treatment-related complication

  5. Overall survival

    Time frame: 3 years

    time between inclusion and the death regardless of cause

  6. Acute and late toxicity during the study

    Time frame: Throughout study completion, up to 3 years

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3

    = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

  7. Quality of life questionnaire - Core 30 (QLQ-C30)

    Time frame: baseline, during treatment (C3J42), 6 month, 1 year

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study 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

Acronym: MEGACEP

Important dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Jun 29, 2016
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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