NCT02817958: MEGACEP

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

Active, enrolled Phase 2 Last updated 21 June 2025

What this trial tests

Phase 2 trial testing Chemotherapy TIP in Penile Cancer in 37 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2016

Primary endpoint
1 September 2026

1 September 2028

Quick facts

Lead sponsor	UNICANCER
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	17 October 2016
Primary completion	1 September 2026
Estimated completion	1 September 2028
Sites	17 locations across France

Drugs / interventions tested

• Chemotherapy TIP — full drug profile →

Conditions studied

• Penile Cancer — all drugs for Penile Cancer →
• Squamous Carcinoma — all drugs for Squamous Carcinoma →

Sponsor

UNICANCER — full company profile →

Who can join

18 and older, male only, with Penile Cancer or Squamous Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• survival without locoregional lymph node recurrence
  Time frame: 24 months
  checked by inguinal ultrasound

Sponsor's own description

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+).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A global approach to improving penile cancer care.
   Bandini M, Ahmed M, Basile G, Watkin N, et al · · 2022 · cited 45× · PMID 34937881 · DOI 10.1038/s41585-021-00557-y
2. Recent Advances in the Management of Penile Cancer: A Contemporary Review of the Literature.
   Stecca CE, Alt M, Jiang DM, Chung P, et al · · 2021 · cited 31× · PMID 33454930 · DOI 10.1007/s40487-020-00135-z
3. Systemic treatment of penile squamous cell carcinoma-hurdles and hopes of preclinical models and clinical regimens: a narrative review.
   Thomas A, do Canto Alvim LM, Rainho CA, Juengel E, et al · · 2021 · cited 7× · PMID 34804850 · DOI 10.21037/tau-20-945
4. Prognostic Markers and Trials in Penile Cancer.
   Naushad N, Deb AA, Agag AA, Serag HA, et al · · 2023 · cited 2× · PMID 37877863 · DOI 10.5152/tud.2023.22225