International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
InPACT
7 other identifiers
interventional
200
2 countries
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2017
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedStudy Start
First participant enrolled
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
August 31, 2026
August 1, 2026
10.1 years
September 23, 2014
August 27, 2026
Conditions
Keywords
Outcome Measures
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.
up to 5 years
Secondary Outcomes (10)
Disease specific survival time
up to 5 years
Number of patients experience a grade 3 or 4 toxicity
up to 5 years
Disease-free survival time
up to 5 years
Occurrence of surgical complication
up to 5 years
Is it possible to achieve pathological nodal assessment after chemotherapy
12 weeks
- +5 more secondary outcomes
Other Outcomes (1)
Acceptability of randomisation
up to 5 years
Study Arms (5)
Arm A - Standard Surgery (ILND)
ACTIVE COMPARATORPart of randomisation 1. The total treatment duration (Inguinal Lymph Node Dissection (ILND)) is estimated to be over 1 day for those patients allocated to Arm A - standard surgery.
Arm B - neoadjuvant chemotherapy
EXPERIMENTALPart of randomisation 1. Patients will receive up to 4 cycles of Paclitaxel, Ifosfamide, and Cisplatin (TIP). Administration on an outpatient basis: Paclitaxel 175 mg/m2, day 1, Ifosfamide 900 mg/m2, days 2-5, Cisplatin 15 mg/m2, days 1-5 Administration on an inpatient basis: Paclitaxel 175 mg/m2, day 1, Ifosfamide 1200 mg/m2, days 1-3, Cisplatin 25 mg/m2, days 1-3
Arm C - neoadjuvant chemoradiotherapy
EXPERIMENTALPart of randomisation 1. Radiotherapy dose is 45Gy in 25 fractions over 5 weeks using 6-10 MV photons to all regions. Concurrent cisplatin 40mg/m2 will be given weekly, subject to GFR\>45mls/min.
Arm P - prophylactic PLND
EXPERIMENTALPart of randomisation 2. Prophylactic pelvic lymph node dissection (PLND) - The total treatment duration is estimated to be over 1 day. Patients who have NOT received neoadjuvant chemoradiotherapy will receive adjuvant chemoradiotherapy: Cisplatin 40mg/m2 will be given weekly, subject to GFR\>45mls/min. Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to: 1. Any macroscopic tumour or pathological lymph nodes 2. Electively to external iliac nodes in patient with high disease burden Patients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone.
Arm Q - Surveillance no prophylactic PLND
NO INTERVENTIONno prophylactic PLND Part of randomisation 2. For patients who have NOT received neoadjuvant chemoradiotherapy: Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to: Any macroscopic tumour or pathological lymph nodes Electively to external iliac nodes in patient with high disease burden
Interventions
Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
Dose 175mg/m2 as part of TIP regimen.
Dose 900mg/m2 as part of TIP regimen.
Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
Treatment with very high energy X-rays (radiotherapy).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Cancer Research, United Kingdomlead
- National Cancer Institute (NCI)collaborator
- ECOG-ACRIN Cancer Research Groupcollaborator
Study Sites (17)
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Velindre NHS Trust
Cardiff, CF14 2TL, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SM2 5PT, United Kingdom
St George's Hospital NHS Foundation Trust
London, SW17 0QT, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
Swansea Bay University Health Board
Swansea, SA6 6NL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steve Nicholson
Mid and South Essex NHS Foundation Trust
- STUDY CHAIR
Curtis Pettaway
University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2014
First Posted
December 2, 2014
Study Start
May 12, 2017
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
August 31, 2026
Record last verified: 2026-08