International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Measurable disease as determined by RECIST (version 1.1) criteria;
Histologically-proven squamous cell carcinoma of the penis,
any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
Disqualifiers
Pure verrucous carcinoma of the penis,
Nonsquamous malignancy of the penis,
Squamous carcinoma of the urethra,
Stage M1,
Trial design
Design model
Parallel
Treatments tested in this trial
ILND - Inguinal Lymph Node Dissection
Procedure/SurgerySurgery to remove the lymph nodes in the groin near to where the cancer first appeared.
Paclitaxel
DrugDose 175mg/m2 as part of TIP regimen.
Ifosfamide
DrugDose 900mg/m2 as part of TIP regimen.
Cisplatin
DrugDose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
Intensity modulated radiation treatment (IMRT)
RadiationTreatment with very high energy X-rays (radiotherapy).
Prophylactic PLND - pelvic lymph node dissection
Procedure/SurgerySurgery 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.
Treatment groups
200 Participants
are divided into 5 treatment groupsGroup A: Arm A - Standard Surgery (ILND)Active comparator 1 intervention
Group B: Arm B - neoadjuvant chemotherapyExperimental treatment 3 interventions
Group C: Arm C - neoadjuvant chemoradiotherapyExperimental treatment 2 interventions
Group D: Arm P - prophylactic PLNDExperimental treatment 1 intervention
Group E: Arm Q - Surveillance no prophylactic PLNDNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Overall survival
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.
Time frame
up to 5 yearsSecondary outcomes
1
Disease specific survival time
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.
Time frame
up to 5 years2
Number of patients experience a grade 3 or 4 toxicity
Time frame
up to 5 years3
Disease-free survival time
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.
Time frame
up to 5 years4
Occurrence of surgical complication
Time frame
up to 5 yearsOther outcomes
1
Acceptability of randomisation
In addition to the outcome measures, the acceptability of both randomisations will be monitored based on the proportion of eligible patients approached for randomisation, the proportion of approached patients consenting to randomisation and the proportion of randomised patients receiving their allocated treatment. This will provide ongoing information regarding the feasibility of the trial successfully completing to target.
Time frame
up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Cancer Research, United Kingdom
Lead sponsor
National Cancer Institute (NCI)
Collaborator
ECOG-ACRIN Cancer Research Group
Collaborator
Source ClinicalTrials.gov