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)
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|ClinicalTrials.gov Identifier: NCT02797626|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
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
- overall survival
- perioperative complications (Clavien-Dindo score)
- quality of life (EORTC QLQ C30, EORTC QLQ TC26)
- long term sequelae
- rate of retrograde ejaculation
|Condition or disease||Intervention/treatment||Phase|
|Stage II A/B Seminomatous Germ Cell Tumors||Procedure: Primary retroperitoneal lymph-node dissection (pRPLND)||Phase 2|
Standard treatment of patients with clinical stage IIA seminoma (isolated retroperitoneal lymph nodes up to 2 cm) is radiotherapy (30Gy) and for clinical stage IIB (isolated retroperitoneal lymph nodes 2-5 cm) is radiotherapy (36Gy, extended iliac field). Alternatively, 3 courses of BEP are equal (1,2,3,4). According to the EAU guidelines 3 cycles of BEP can be substituted for 4 x PE in patients with contraindications for bleomycin. Radiotherapy as well as chemotherapy has several side effects: multiple studies show significant long term toxicity after cisplatin chemotherapy such as cardiotoxicity or nephrotoxicity (5,6,7,8, 9). Patients after radiotherapy show a significant increased rate of secondary malignancies during long term follow-up (relative risk between 1.3 and 1.4) (13, 14).
There are no reliable data on recurrences of patients with seminoma in CS II who have undergone surgery only. After the publication of Warszawski et al in 1997 primary RPLND in seminoma has not been performed on a routine basis (10). However, seminoma metastasis follows the same anatomical principles as non-seminoma and is primarily lymphatic. In clinical stage I high risk seminoma patients the overall recurrence rate without adjuvant therapy is ~ 30%, in CS IIB patients after radiotherapy at around 18%, respectively (11,12). If seminoma stage II patients could achieve a less than 10% recurrence rate after surgery, surveillance as well as a single course adjuvant chemotherapy would again be justified. The overall burden of standard treatment with 3 or 4 courses of chemotherapy could thereby considerably reduced. With a recurrence rate of > 30% (exceeding the upper border of the confidence interval) every third patient would require surgery and chemotherapy and the overall treatment burden would not justify this approach.
Thus, the hypothesis of this trial is currently an overtreatment of patients with low volume metastasis either initially diagnosed or as recurrence with 3 courses BEP chemotherapy as recommended standard treatment in most of these patients. In addition, surgical techniques have evolved and laparoscopic robot-assisted RPLND seems possible in unilateral low stage disease.
In order to clarify the role of primary RPLND in this patient cohort, the progression-free survival has to be explored in a single arm non-randomized trial. Only if the recurrence rate does not exceed the published figures further adjuvant treatment is justified. In a subsequent trial patients may then be selected based on prognostic parameters to receive surveillance after primary RPLND only or to be treated by 1 course of BEP in cases of higher relapse figures. Therefore, this trial may serve as first step to improve the overall treatment burden in patients with clinical stage II disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Single-arm 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)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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)
- progression-free survival [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797626
|Contact: Achim Lusch, M.D.||firstname.lastname@example.org|
|Contact: Achim Lusch, M.D.|
|Departement of Urology, Heinrich Heine University Duesseldorf||Recruiting|
|Duesseldorf, NRW, Germany, 40225|
|Contact: Achim Lusch, M.D. email@example.com|
|Principal Investigator:||Peter Albers, M.D., PhD||Department of Urology, Heinrich Heine University, Duesseldorf, Germany|
|Principal Investigator:||Achim Lusch, M.D.||Department of Urology, Heinrich Heine University, Duesseldorf, Germany|