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

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

Arms & interventions

• ProcedureILND - Inguinal Lymph Node Dissection

  Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.

• DrugPaclitaxel

  Dose 175mg/m2 as part of TIP regimen.

• DrugIfosfamide

  Dose 900mg/m2 as part of TIP regimen.

• DrugCisplatin

  Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)

• RadiationIntensity modulated radiation treatment (IMRT)

  Treatment with very high energy X-rays (radiotherapy).

• ProcedureProphylactic 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.

Outcome measures

Eligibility criteria