International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ILND - Inguinal Lymph Node Dissection, Paclitaxel, Ifosfamide, Cisplatin.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of the Penis, Usual Type. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Primary outcome measures
- Overall survival [Time frame: up to 5 years]
Secondary outcome measures (10)
- Disease specific survival time [Time frame: up to 5 years]
- 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]
- Occurrence of surgical complication [Time frame: up to 5 years]
- Is it possible to achieve pathological nodal assessment after chemotherapy [Time frame: 12 weeks]
- Quality of life [Time frame: Baseline, 3, 6, 9, 12, 18, 24 and 36 months]
- Occurrence of Pathological complete remission [Time frame: Time to complete remission after randomisation]
- Operability [Time frame: 2-6 weeks]
- Occurrence of Lower limb/scrotal oedema [Time frame: up to 5 years]
- On-schedule delivery of neoadjuvant therapy [Time frame: After randomisation up to 12 weeks]
Eligibility criteria
Inclusion criteria
- Written informed consent
- Measurable disease as determined by RECIST (version 1.1) criteria;
- Histologically-proven squamous cell carcinoma of the penis,
- Stage:
- any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
- any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
- any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
- Performance Status ECOG 0, 1 or 2.
Exclusion criteria
- Pure verrucous carcinoma of the penis,
- Nonsquamous malignancy of the penis,
- Squamous carcinoma of the urethra,
- Stage M1,
- Previous chemotherapy or chemoradiotherapy,
- Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Los Angeles County-USC Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- Moffitt Cancer Center — Tampa
- Grady Health System — Atlanta
- Emory University Hospital/Winship Cancer Institute — Atlanta
- University of Chicago Comprehensive Cancer Center — Chicago
- Mayo Clinic — Rochester
- Ohio State University Comprehensive Cancer Center — Columbus
- … and 3 more centers
United Kingdom · 6 centers
- Velindre NHS Trust — Cardiff
- University Hospitals of Leicester NHS Trust — Leicester
- The Royal Marsden NHS Foundation Trust — London
- St George's Hospital NHS Foundation Trust — London
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich
- Swansea Bay University Health Board — Swansea
Identifiers
NCT: NCT02305654 · ICR CTSU/2014/10048 · CRUK/13/005 · 13580965 · EA8134 · IRCI004 · 2015-001199-23