MedTrace Logo

Trial to Evaluate Progression Free Survival With Primary Retroperitoneal Lymph-node Dissection (pRPLND) Only in Patients With Seminomatous Testicular Germ Cell Tumors With Clinical Stage IIA/B (PRIMETEST)

NCT02797626 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-13

No results posted yet for this study

Summary

Primary objective:

to evaluate progression-free survival in patients with clinical stage II A/B seminomatous germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without adjuvant treatment

Secondary objectives:

* overall survival
* perioperative complications (Clavien-Dindo score)
* quality of life (EORTC QLQ C30, EORTC QLQ TC26)
* long term sequelae
* rate of retrograde ejaculation

Conditions

  • Stage II A/B Seminomatous Germ Cell Tumors

Interventions

PROCEDURE

Primary retroperitoneal lymph-node dissection (pRPLND)

Open or laparoscopic robotic-assisted nerve-sparing retroperitoneal lymph node dissection (modified template RPLND, if possible ipsilateral nerve-sparing)

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Peter Albers, M.D., PhD · Department of Urology, Heinrich Heine University, Duesseldorf, Germany

  • Achim Lusch, M.D. · Department of Urology, Heinrich Heine University, Duesseldorf, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02797626 on ClinicalTrials.gov