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Study on the Effects of Chemotherapy with Paclitaxel, Ifosfamide, and Cisplatin for Patients with Squamous Cell Carcinoma of the Penis and Lymph Node Metastasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as squamous cell carcinoma of the penis. The study is evaluating the effects of a combination of treatments, including surgery and chemotherapy, on the lymph nodes in the groin area. The chemotherapy treatment being tested is called TIP, which includes three medications: paclitaxel, ifosfamide, and cisplatin. These medications are given as a solution through a vein, known as intravenous infusion. The purpose of the study is to assess how well this combination of treatments works in preventing the cancer from coming back in the lymph nodes.

Participants in the study will receive the chemotherapy treatment along with a surgical procedure called lymphadenectomy, which involves removing lymph nodes from the groin area. The study will monitor the participants over a period of time to see if the cancer returns in the lymph nodes. Other medications, such as methylprednisolone, ranitidine, mesna, aprepitant, and dexchlorpheniramine maleate, may also be used to help manage side effects or support the main treatment. These medications are administered either orally or through injection.

The study aims to provide valuable information on the effectiveness of combining chemotherapy with surgery in treating this type of cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the treatment's impact on their health. The study is expected to continue until the end of 2027, with regular check-ups and assessments to track the progress of the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have already met the necessary criteria, including a confirmed diagnosis of squamous cell carcinoma of the penis with inguinal lymph node metastases.

    The patient will have signed a consent form after receiving and understanding the information about the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the patient's overall health and eligibility for the treatment plan.

    This assessment includes blood tests to check liver and kidney function, as well as heart function tests.

  3. Step 3

    Chemotherapy treatment

    The patient will receive a combination of chemotherapy drugs known as TIP, which includes paclitaxel, ifosfamide, and cisplatin.

    These medications will be administered through an intravenous (IV) line.

    The treatment cycle will be repeated every three weeks, with the exact number of cycles determined by the patient's response to the treatment.

  4. Step 4

    Supportive medications

    To manage side effects, the patient will receive additional medications such as methylprednisolone (orally and IV), ranitidine (IV), mesna (IV), aprepitant (orally), and dexchlorpheniramine maleate (IV).

    These medications help reduce nausea, protect the stomach lining, and prevent allergic reactions.

  5. Step 5

    Surgical procedure

    Following chemotherapy, the patient will undergo a surgical procedure called bilateral lymphadenectomy to remove affected lymph nodes in the groin area.

    This surgery aims to prevent the spread of cancer to other parts of the body.

  6. Step 6

    Follow-up and monitoring

    Regular follow-up appointments will be scheduled to monitor the patient's recovery and check for any signs of cancer recurrence.

    These appointments will include physical examinations and imaging tests, such as inguinal ultrasounds, to ensure there is no locoregional lymph node recurrence.

  7. Step 7

    End of study

    The study is expected to conclude by December 31, 2027.

    The primary goal is to evaluate survival without locoregional lymph node recurrence over a 24-month period.

Who can join the trial?

17 criteria

  • Must have a penile tumor confirmed by a lab test, regardless of the initial treatment, such as amputation, conservative surgery, or brachytherapy.
  • Must have normal levels of calcium and potassium in the blood.
  • Must have liver enzymes (AST and ALT) and bilirubin within specific normal limits. If you have Gilbert's disease, bilirubin can be slightly higher.
  • Must have a creatinine clearance of at least 60 mL/min, which is a measure of kidney function.
  • Must have a left ventricular ejection fraction (LVEF) greater than 50%, which is a measure of heart function.
  • Must have read the information note and signed a consent form to participate.
  • If of reproductive age, must agree to use two methods of birth control during the study and for 6 months after the last treatment dose.
  • Must be able to follow the study requirements, including scheduled visits and procedures.
  • Must be covered by a social security scheme.
  • Must have mobile lymph nodes that can be felt, or if no lymph nodes can be felt, must have a certain risk of lymph node involvement.
  • Must have lymph node involvement that has spread.
  • Must not have cancer that has spread to other parts of the body (M0 or Mx).
  • Must be at least 18 years old.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which measures daily living abilities.
  • Must have a white blood cell count of at least 1.5 g/L.
  • Must have a hemoglobin level of at least 9 g/dL, which is a measure of red blood cells.
  • Must have a platelet count of at least 100,000 per mm³, which helps with blood clotting.

Who cannot join the trial?

5 criteria

  • Patients who do not have **penis carcinoma** cannot participate. **Penis carcinoma** is a type of cancer that affects the penis.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who do not have **inguinal lymph node metastases** cannot participate. **Inguinal lymph node metastases** means that cancer has spread to the lymph nodes in the groin area.
  • Patients who have not undergone treatment combining **adjuvant or neoadjuvant TIP chemotherapy** with **inguinal lymph node dissection** cannot participate. **Adjuvant chemotherapy** is treatment given after the main treatment to lower the risk of cancer returning. **Neoadjuvant chemotherapy** is treatment given before the main treatment to shrink a tumor. **TIP chemotherapy** is a specific combination of cancer drugs. **Inguinal lymph node dissection** is a surgery to remove lymph nodes in the groin area.
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Investigated drugs

  • TIP Chemotherapy

    is a combination of three chemotherapy drugs used to treat certain types of cancer, including squamous cell carcinoma of the penis. This therapy aims to kill cancer cells and reduce the size of tumors. It is often used before or after surgery to improve the chances of successful treatment. In this trial, TIP chemotherapy is used to help prevent the recurrence of cancer in the lymph nodes.

  • Bilateral Lymphadenectomy

    is a surgical procedure that involves the removal of lymph nodes from both sides of the groin area. This is done to remove cancerous lymph nodes and to help prevent the spread of cancer to other parts of the body. In this trial, the procedure is combined with chemotherapy to improve patient outcomes.

What is already known about the treatment

TIP Chemotherapy – This medication is administered intravenously and is used in the treatment of squamous cell carcinoma of the penis, particularly when there are metastases in the inguinal lymph nodes. TIP chemotherapy is currently being evaluated in clinical trials to determine its effectiveness in preventing the recurrence of lymph node metastases. The main therapeutic indication is for patients with penile cancer who have inguinal lymph node involvement. At the molecular level, TIP chemotherapy works by interfering with the DNA replication process in cancer cells, thereby inhibiting their growth and proliferation. It is classified as a combination chemotherapy regimen, typically involving drugs like paclitaxel, ifosfamide, and cisplatin.

Investigated diseases

Penile Cancer – Penile cancer is a rare type of cancer that occurs on the skin or in the tissues of the penis. It often begins as a small, wart-like growth or sore on the penis, which may not heal and can become larger over time. The most common type is squamous cell carcinoma, which tends to grow slowly and can spread to nearby lymph nodes. As the disease progresses, it may cause symptoms such as changes in skin color, thickening of the skin, or a lump on the penis. If the cancer spreads, it can affect the lymph nodes in the groin area, leading to swelling or pain. Early detection and monitoring are crucial for managing the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512827-36-00Protocol codeUC_0160/1406Estimated enrolment37 patientsSponsorUnicancer

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