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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
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Brief 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

Condition or disease Intervention/treatment Phase
Stage II A/B Seminomatous Germ Cell Tumors Procedure: Primary retroperitoneal lymph-node dissection (pRPLND) Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Primary RPNLD 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)




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed seminomatous testicular germ cell tumor
  • inguinal, paraaortic or retroperitoneal lymph nodes classified as local or regional unilateral lymph node metastasis by contrast CT or MRI
  • maximum dimensions of lymph node metastasis: single mass of max. 5.0 cm in transverse CT diameter multiple metastases in a unilateral field with single max. diameter of 5.0 cm (UICC IIB)

patients with serum tumour marker elevation at the time of CT staging are eligible if the elevated human chorionic gonadotropin (hCG) directly before RPLND does not exceed 5 IU/L

  • patients qualify for this trial with following scenarios

    1. initial diagnosis of UICC clinical stage IIA/IIB disease
    2. recurrence after surveillance for clinical stage I
    3. recurrence after adjuvant treatment of clinical stage I seminoma with 1 x carboplatin AUC7
  • curative treatment is intended
  • patient´s age above 18 years
  • able to communicate well with the investigator, to understand and comply with the requirements of the study, to understand and sign the written informed consent.

Exclusion Criteria:

  • non-seminomatous germ cell tumors
  • germ cell tumor-related AFP elevation suspicious of non-seminoma
  • metastatic lymph node mass with greatest dimension >5 cm (CS IIC)
  • other metastasis (CS III)
  • patients with prior scrotal or retroperitoneal surgery due to other diseases than germ cell cancer
  • patient underwent chemotherapy other than adjuvant Carboplatin monotherapy
  • patient underwent radiotherapy of the retroperitoneum
  • patient in reduced general condition or with live threatening disease
  • patient has a psychiatric disease
  • patient does not have sufficient knowledge of German language

Information from the National Library of Medicine

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


Contacts
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Contact: Achim Lusch, M.D. achim.lusch@med.uni-duesseldorf.de
Contact: Achim Lusch, M.D.

Locations
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Germany
Departement of Urology, Heinrich Heine University Duesseldorf Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Achim Lusch, M.D.       achim.lusch@med.uni-duesseldorf.de   
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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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

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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02797626     History of Changes
Other Study ID Numbers: 2015053664
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders