NCT02305654

International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

Conditions

• Squamous Cell Carcinoma of the Penis, Usual Type

Interventions

Type	Name	Description
PROCEDURE	ILND - Inguinal Lymph Node Dissection	Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
DRUG	Paclitaxel	Dose 175mg/m2 as part of TIP regimen.
DRUG	Ifosfamide	Dose 900mg/m2 as part of TIP regimen.
DRUG	Cisplatin	Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
RADIATION	Intensity modulated radiation treatment (IMRT)	Treatment with very high energy X-rays (radiotherapy).
PROCEDURE	Prophylactic PLND - pelvic lymph node dissection	Surgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.

Timeline

• Start date: 2017-05-12
• Primary completion: 2027-05-31
• Completion: 2027-11-30
• First posted: 2014-12-02
• Last updated: 2025-04-02

Locations

17 sites across 2 countries: United States, United Kingdom