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DEfeating PEnile CAncer-2

RecruitingNAAges 18 Years - anyMaleUniversity Hospital Tuebingen
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In plain words

What the trial is, and whether it could suit you

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. Being in apprehension of these postsurgical adversities, physicians are often reluctant with indicating this procedure, thus depriving their patients of the vital prognosis-relevant care. In the sum, these obstacles inevitably result in inferior oncologic outcomes. Aiming to decrease postsurgical detrimental sequelae, several attempts to modify radicality of the technique, including inter alia a radioguided approach of sentinel lymph node resection, have bee

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion 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 * pTa-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 anticoagulants. Anticoagulation is accepted according to the surgeon's practice. * 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. Exclusion Criteria: * 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), sentinel or other 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.
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What it tests

  • open inguinal lymphadenectomy
  • robot-assisted inguinal lymphadenectomy
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Where

9 sites
Charité- Universitätsmedizin Berlin
Berlin, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
University Medical Center of Johannes Gutenberg-University
Mainz, Germany
Medical Faculty Mannheim
Mannheim, Germany
Ludwig Maximilian University Hospital
München, Germany
University Medicine Rostock
Rostock, Germany
University Hospital Tübingen
Tübingen, Germany

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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