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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

UK - InPACT Senior Trial Manager 02087224261
InPACT-icrctsu@icr.ac.uk


US/Canada - InPACT DA for EA8134 (857)504-2900


Study Location:

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Be Part of Research - Trial Details - International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

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

Recruiting

Open to: MALE

Age: 18.0 - N/A

Medical Conditions


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2017 May 2025

INTERVENTIONAL

Intervention Type : PROCEDURE
Intervention Description : Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.

Intervention Arm Group : Arm A - Standard Surgery (ILND);

Intervention Type : DRUG
Intervention Description : Dose 175mg/m2 as part of TIP regimen.

Intervention Arm Group : Arm B - neoadjuvant chemotherapy;

Intervention Type : DRUG
Intervention Description : Dose 900mg/m2 as part of TIP regimen.

Intervention Arm Group : Arm B - neoadjuvant chemotherapy;

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

Intervention Arm Group : Arm B - neoadjuvant chemotherapy;Arm C - neoadjuvant chemoradiotherapy;

Intervention Type : RADIATION
Intervention Description : Treatment with very high energy X-rays (radiotherapy).

Intervention Arm Group : Arm C - neoadjuvant chemoradiotherapy;

Intervention Type : PROCEDURE
Intervention Description : 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.

Intervention Arm Group : Arm P - prophylactic PLND;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Velindre NHS Trust
    Cardiff
    CF14 2TL
  • The Royal Marsden NHS Foundation Trust
    London
    SM2 5PT
  • Swansea Bay University Health Board
    Swansea
    SA6 6NL
  • St George's Hospital NHS Foundation Trust
    London
    SW17 0QT
  • University Hospitals of Leicester NHS Trust
    Leicester
    LE1 5WW
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Norwich
    NR4 7UY

UK - InPACT Senior Trial Manager 02087224261
InPACT-icrctsu@icr.ac.uk


US/Canada - InPACT DA for EA8134 (857)504-2900



The study is sponsored by Institute of Cancer Research, United Kingdom and is in collaboration with National Cancer Institute (NCI); ECOG-ACRIN Cancer Research Group.





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Read full details for Trial ID: NCT02305654
Last updated 03 June 2024

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