A Phase 2 interventional study of Chemotherapy TIP in Penile Cancer and Squamous Carcinoma, sponsored by UNICANCER. Active, not recruiting at 17 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by UNICANCER · Phase 2, Interventional, and Treatment
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+).
80 studies on the registry are indexed under Penile Neoplasms; 25 are open to participants now.
This study's planned enrollment of 37 is close to the median of 37 across 64 interventional studies indexed under Penile Neoplasms.
Browse Penile Neoplasms studies →UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lymphadenectomy (+/- sentinel node) + adjuvant chemotherapy TIP modified bilateral lymphadenectomy 4 cycles every 21 days
Drug: Chemotherapy TIP
fine needle biopsy or sentinel node + neoadjuvant chemotherapy TIP followed by a lymphadenectomy modified bilateral lymphadenectomy 4 cycles every 21 days
Drug: Chemotherapy TIP
Paclitaxel, ifosfamide, and cisplatin
Also known as: Chemotherapy TIP (paclitaxel, ifosfamide et cisplatine)
survival without locoregional lymph node recurrence
checked by inguinal ultrasound
Time frame: 24 months
Complete response rate for patients in neoadjuvant chemotherapy
lack of residual tumor post surgical histopathology
Time frame: 6 months
Survival without locoregional lymph node recurrence
time between inclusion and locoregional recurrence or last evaluation
Time frame: 3 years
Survival without metastasis
time between inclusion and the date of occurrence of metastases
Time frame: 3 years
Specific survival
time between inclusion and date of death from penile cancer or treatment-related complication
Time frame: 3 years
Overall survival
time between inclusion and the death regardless of cause
Time frame: 3 years
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.
Time frame: Throughout study completion, up to 3 years
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.
Time frame: baseline, during treatment (C3J42), 6 month, 1 year
Plan to share: 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UNICANCER