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

Conditions

• Squamous Cell Carcinoma of the Penis, Usual Type

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• ECOG-ACRIN Cancer Research Group

  collaborator NETWORK

• Institute of Cancer Research, United Kingdom

  lead OTHER

Principal Investigators

• Steve Nicholson · Mid and South Essex NHS Foundation Trust

• Curtis Pettaway · University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-12

Primary Completion

2027-05-31

Completion

2027-11-30

Countries

• United States
• United Kingdom

Study Locations