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NCT02305654 · ClinicalTrials.gov registry record · Phase 3
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
A Phase 3 study of Squamous Cell Carcinoma of the Penis, Usual Type, sponsored by Institute of Cancer Research, United Kingdom.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 17
- Study locations
NCT02305654 is a Phase 3 study of Squamous Cell Carcinoma of the Penis, Usual Type that is actively recruiting participants, run by Institute of Cancer Research, United Kingdom. The registered enrollment target is 200 participants. The trial reports 17 study locations across 10 states.
The verdict
NCT02305654, a Phase 3 study of Squamous Cell Carcinoma of the Penis, Usual Type, is actively recruiting participants, sponsored by Institute of Cancer Research, United Kingdom.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 17
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Paclitaxel
- DRUG Ifosfamide
- PROCEDURE ILND - Inguinal Lymph Node Dissection
- RADIATION Intensity modulated radiation treatment (IMRT)
Study Locations (17)
Other
- 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
California
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Georgia
- Grady Health System - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Minnesota
- Mayo Clinic - Rochester
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-05-12 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02305654
The ClinicalTrials.gov registry entry for NCT02305654 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institute of Cancer Research, United Kingdom, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Squamous Cell Carcinoma of the Penis, Usual Type appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT02305654 reports 17 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02305654 about?
NCT02305654 is a clinical study titled "International Penile Advanced Cancer Trial (International Rare Cancers Initiative 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 t...
What is the current status of trial NCT02305654?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2017-05-12. Estimated completion is 2027-11-30.
What conditions does trial NCT02305654 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Penis, Usual Type.
What interventions are being tested in trial NCT02305654?
The interventions under investigation include: Cisplatin (DRUG), Paclitaxel (DRUG), Ifosfamide (DRUG), ILND - Inguinal Lymph Node Dissection (PROCEDURE), Intensity modulated radiation treatment (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT02305654?
This trial is sponsored by Institute of Cancer Research, United Kingdom, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02305654 being conducted?
This trial has 17 study locations across California, Florida, Georgia, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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