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New treatment option for Penile Cancer
Official title DEfeating PEnile CAncer-2
ClinicalTrials.gov ID: NCT07378670
What this study is testing
- What it's testing
- Open inguinal lymphadenectomy (O-ILAD) is the current standard of care for invasive staging and simultaneously the curative approach for patients with PeCa and elevated risk for or clinically detectable lymphatic disease in the groin. The high rate of complications of this surgical procedure, which are often mutilating and associated with a long-term convalescence, leads to a critical delay in initiation of adjuvant systemic therapy.
- 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
- 1\. Patient has provided written informed consent.
- 2\. Male patient ≥ 18 years at time of signing the informed consent form.
- 3\. Patient has histologically proven penile squamous cell carcinoma.
- 4\. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1/2) inguinal lymphadenectomy, i.e.:
- pT1a, G2, cN0 OR
You likely can't join if
- 1\. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging).
- 2\. Patient has distant metastases.
- 3\. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa.
- 4\. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or...
- 5\. Patient participates in competing trials affecting the effects of the surgery or outcome measures.
- 6\. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its...
See the full eligibility criteria
- 1\. Patient has provided written informed consent.
- 2\. Male patient ≥ 18 years at time of signing the informed consent form.
- 3\. Patient has histologically proven penile squamous cell carcinoma.
- 4\. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1/2) inguinal lymphadenectomy, i.e.:
- pT1a, G2, cN0 OR
- pT1b- pT3, any G, cN0 OR
- pT1-pT3, any G, cN1-2
- 5\. Patients has adequate hepatic, renal and bone marrow function:
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1.5 x 109 /L
- Platelets ≥ 100 x 109 /L
- International normalized ratio (INR) / activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of...
- 6\. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
- 7\. Performance status of the patient is judged by the treating physician as appropriate to undergo surgery.
- 1\. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging).
- 2\. Patient has distant metastases.
- 3\. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa.
- 4\. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or radiotherapy in the groin or pelvic area.
- 5\. Patient participates in competing trials affecting the effects of the surgery or outcome measures.
- 6\. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences.
- 7\. Patient has any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
- 8\. Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- 9\. Patient is unable to consent because he does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Dresden, Germany
- Erlangen, Germany
- Mainz, Germany
- Mannheim, Germany
- München, Germany
- Rostock, Germany
- Tübingen, Germany
- Ulm, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Berlin, Germany; Dresden, Germany; Erlangen, Germany; Mainz, Germany; Mannheim, Germany; München, Germany and 3 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.