Evaluation of Lymphadenectomy and Chemotherapy TIP (paclitaxel, ifosfamide and cisplatin) on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unicancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Oct 2016 → ongoing

Decision date (initial)

2024-05-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ligue contre le cancer

External identifiers

EU CT number

2024-512827-36-00

EudraCT number

2014-004678-41

ClinicalTrials.gov

NCT02817958

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Evaluation of the rate of survival without locoregional lymph node recurrence (inguinal and iliac) in patients with pN+ squamous cell carcinoma of the penis presenting with inguinal lymph node metastases after treatment combining adjuvant or neoadjuvant TIP chemotherapy with inguinal lymph node dissection

Secondary objectives 7

1. Evaluation of the complete response rate for patients in neoadjuvant chemotherapy at 24 months for patients treated by neo adjuvant chemotherapy
2. Evaluation of survival without locoregional lymph node recurrence at 3 years
3. Evaluation of survival without metastasis at 3 years
4. Evaluation of specific survival at 3 years
5. Evaluation of overall survival at 3 years
6. Evaluation of acute and late toxicity during the study
7. Evaluation of quality of life

Conditions and MedDRA coding

Penis carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 17

1. Penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Patients with capsular involvement if inguinal lymph nodes are affected exclusively Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2
3. Metastatic lymph node involvement
4. Patients M0 or Mx
5. Age ≥18 ans
6. Eastern Cooperative Oncology Group (ECOG) 0-1
7. Leucocytes ≥1.5 g/L
8. Hemoglobin ≥9 g/dL
9. Platelets ≥100 000/mm³
10. Normal calcemia and kaliemia
11. 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
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%
14. Patients having received, read the information note and signed consent
15. 15. 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,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme

Exclusion criteria 14

1. Fixed inguinal lymph nodes
2. Iliac lymph nodes
3. Prior chemotherapy for squamous cell carcinoma of the penis
4. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
5. Patients treated with phenytoin
6. Patients with hearing loss >Grade 1 (CTCAE V4.03),
7. Patients with cardiopulmonary disease-indicating against overhydration
8. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell
9. Patient received a live attenuated vaccine within 30 days prior to inclusion
10. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial
11. Patients deprived of their liberty or under court protection including guardianship
12. 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
13. Immunocompromised patients including with known seropositivity (HIV),
14. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Survival without locoregional lymph node recurrence [ Time Frame: 24 months ] checked by inguinal ultrasound

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris Cedex 13

Postcode

75654

Country

France

Scientific contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Public contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications