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Penile CancerPhase 2MEGACEPNCT02817958

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

A Phase 2 study testing Chemotherapy TIP in people with Penile Cancer and Squamous Carcinoma, run by UNICANCER at 17 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Penile Cancer, Squamous Carcinoma
What is being tested?
Chemotherapy TIP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
17 sitesFrance
Study dates
17 Oct 2016to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • ICO-Paul Papin

    Angers, 49055

  • Chr Besancon

    Besançon, 25000

  • Hôpital SAINT ANDRE

    Bordeaux, 33075

  • Centre FRANCOIS BACLESSE

    Caen, 14076

  • Chru Gabriel Montpied

    Clermont-Ferrand, 63000

  • Ch de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69008

  • Chu Lyon Sud

    Lyon, 69310

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Institut de Cancerologie de Lorraine

    Nancy, 54519

  • Clinique Urologique- Chu Hotel Dieu

    Nantes, 44093

  • Institut de Cancerologie Du Gard - Centre Oncogard

    Nîmes, 300029

  • Hopital Saint Louis

    Paris, 75010

  • Chu de Rouen

    Rouen, 76031

  • ICO-René Gauducheau

    Saint-Herblain, 44805

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31059

Other trials in France

About this study

Official 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

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.

Read more

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+).

Being tested
Chemotherapy TIP
Keywords
inguinal lymph nodes, penile cancer, squamous, TIP chemotherapy
Medical subject headings
Penile Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemotherapy TIPDrug

    Also called Chemotherapy TIP (paclitaxel, ifosfamide et cisplatine)

    Paclitaxel, ifosfamide, and cisplatin

Study groups in NCT02817958
Study groupRoleWhat they receive
A-Adjuvant Chemotherapy TIPExperimentalLymphadenectomy (+/- sentinel node) + adjuvant chemotherapy TIP modified bilateral lymphadenectomy 4 cycles every 21 days
Receives: Drug: Chemotherapy TIP
B-Neoadjuvant Chemotherapy TIPExperimentalfine needle biopsy or sentinel node + neoadjuvant chemotherapy TIP followed by a lymphadenectomy modified bilateral lymphadenectomy 4 cycles every 21 days
Receives: Drug: Chemotherapy TIP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. survival without locoregional lymph node recurrence

    checked by inguinal ultrasound

    Measured: 24 months

Secondary outcomes (7)

  1. Complete response rate for patients in neoadjuvant chemotherapy

    lack of residual tumor post surgical histopathology

    Measured: 6 months

  2. Survival without locoregional lymph node recurrence

    time between inclusion and locoregional recurrence or last evaluation

    Measured: 3 years

  3. Survival without metastasis

    time between inclusion and the date of occurrence of metastases

    Measured: 3 years

  4. Specific survival

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

    Measured: 3 years

  5. Overall survival

    time between inclusion and the death regardless of cause

    Measured: 3 years

  6. Acute and late toxicity during the study

    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.

    Measured: Throughout study completion, up to 3 years

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start17 Oct 2016
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817958
Sponsor's protocol ID
UC-0160/1406
Other IDs
AFU-GETUG 25, 2014-004678-41, 2014
Acronym
MEGACEP
Status last verified
Jun 2025
First submitted
24 May 2016
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy TIP in people with Penile Cancer and Squamous Carcinoma, run by UNICANCER at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survival without locoregional lymph node recurrence (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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