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New treatment option for Squamous Cell Carcinoma of the Penis, Usual Type
Official title International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
ClinicalTrials.gov ID: NCT02305654
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, being studied as a potential treatment for squamous cell carcinoma of the penis, usual type.
Also referred to as Taxol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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;
You likely can't join 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Cardiff, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Norwich, United Kingdom
- Swansea, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States; Columbus, Ohio, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.