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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

Brief 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


Detailed Summary:
Sponsor: Institute of Cancer Research, United Kingdom

Current Primary Outcome: Overall survival [ Time Frame: up to 5 years ]

The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease specific survival time [ Time Frame: up to 5 years ]
    Disease-specific survival time which is defined in whole days as the time from the date of randomisation to the date of death specifically from disease; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up and for those whose death is reported as non-disease specific then the survival time will be censored at date of death.
  • Number of patients experience a grade 3 or 4 toxicity [ Time Frame: up to 5 years ]
  • Disease-free survival time [ Time Frame: up to 5 years ]

    Disease-free survival time (DFST) which is defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFST will be censored at the date last known to be alive and free of disease or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin rather than date of randomisation.

    Subsidiary outcome measures will be

    • locoregional recurrence free survival time (LRFST).
    • distant metastases free survival time (DMFST).
    • A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin for all these outcome measures rather than date of randomisation.
  • Occurrence of surgical complication [ Time Frame: up to 5 years ]
  • Is it possible to achieve pathological nodal assessment after chemotherapy [ Time Frame: 12 weeks ]
    Feasibility of pathological nodal assessment after chemotherapy which is recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy.
  • Quality of life [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24 and 36 months ]
    Measured using the EORTC-QLQC30 and Lymphodema-QL
  • Occurrence of Pathological complete remission [ Time Frame: Time to complete remission after randomisation ]

    Measured for all patients in InPACT-neoadjuvant:

    Absolute absence of disease on histological examination

  • Operability [ Time Frame: 2-6 weeks ]
    Measured for all trial patients in InPACT-neoadjuvant. Operability which will be recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur.
  • Occurrence of Lower limb/scrotal oedema [ Time Frame: up to 5 years ]
    Occurrence of Lower limb/scrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema
  • On-schedule delivery of neoadjuvant therapy [ Time Frame: After randomisation up to 12 weeks ]
    Feasibility of on-schedule delivery of neoadjuvant therapy


Original Secondary Outcome: Same as current

Information By: Institute of Cancer Research, United Kingdom

Dates:
Date Received: September 23, 2014
Date Started: April 2015
Date Completion:
Last Updated: November 27, 2014
Last Verified: November 2014