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)
Indikation (Clinical Trials):
Neoplasms, Germ Cell and Embryonal, Testicular Neoplasms
Geschlecht:
Männer
Altersgruppe:
Alle
Phase:
Phase 2
Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborator:
-
Studienleiter
Peter Albers, M.D., PhD Principal Investigator Department of Urology, Heinrich Heine University, Duesseldorf, Germany Achim Lusch, M.D. Principal Investigator Department of Urology, Heinrich Heine University, Duesseldorf, Germany
Departement of Urology, Heinrich Heine University Duesseldorf 40225 Duesseldorf (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Achim Lusch, M.D. E-Mail: achim.lusch@med.uni-duesseldorf.de» Ansprechpartner anzeigen
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.
- 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
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)
Quelle: ClinicalTrials.gov
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