JOURNAL ONKOLOGIE – STUDIE

PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06144736

Studienbeginn:
August 2023

Letztes Update:
22.11.2023

Wirkstoff:
Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin

Indikation (Clinical Trials):
Seminoma

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Heinrich-Heine University, Duesseldorf

Collaborator:
-

Studienleiter

Yue Che
Principal Investigator
University Hospital of Düsseldorf

Kontakt

Yue Che
Kontakt:
Phone: 00492118118110
E-Mail: yue.che@med.uni-duesseldorf.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Duesseldorf
Duesseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yue Che
E-Mail: yue.che@med.uni-duesseldorf.de

Peter Albers
E-Mail: peter.albers@med.uni-duesseldorf.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Testicular cancer stands as the most prevalent cancer among young men, boasting a highly

favorable prognosis characterized by almost unaltered long-term survival even in advanced

stages. However, traditional treatments like chemotherapy and radiation are linked to

significant long-term toxicity and increased rates of secondary malignancies. Particularly,

late toxicities, mainly cardiovascular, substantially diminish overall survival by

approximately 6-7 years. To circumvent unnecessary acute and long-term toxicities associated

with radiation or chemotherapy, it's crucial to explore alternative therapeutic avenues

through personalized, less toxic approaches.

Building upon the hypothesis-generating PRIMETEST I study, PRIMETEST II is a single-arm,

non-randomized prospective study. It aims to explore novel and personalized predictive

parameters for recurrence following a robot-assisted primary retroperitoneal lymph node

dissection (pRA-RPLND) in patients with clinical stage IIA/B seminoma (involving low-volume

metastatic disease up to 5 cm). These patients represent a rare subgroup among testicular

cancer patients, making a randomized comparison of treatment options impractical due to their

low prevalence. The overarching goal is to reduce long-term toxicity in this young cohort of

cancer patients and enhance their quality of life through personalized clinical and molecular

predictions.

PRIMETEST I has indicated that pRA-RPLND in patients with clinical stage IIA/B seminoma led

to a 70% recurrence-free survival at 32 months' follow-up. These findings suggest that

pRA-RPLND could serve as an alternative to standard therapies (chemotherapy, radiotherapy)

for a highly selective group of patients, effectively preventing excessive toxicity.

PRIMETEST I has already identified several potential factors that predict which patients are

more likely to benefit from surgical therapy alone.

In the novel prospective setting of PRIMETEST II, the study tests the identified predictive

factors for recurrence. Patients exhibiting presumably low-risk features (about 70% of

patients) will continue with surgery alone. Those with a presumed higher risk of recurrence

will undergo robot-assisted surgery and have the option of receiving adjuvant treatment (one

cycle of cisplatin, etoposide, and bleomycin). The primary endpoint is a three-year

recurrence-free survival, estimated to exceed 90%. Additional objectives include exploring

new predictors of recurrence at both molecular and clinical levels by analyzing serum and

tissue samples from the primary tumor and metastases.

This innovative approach anticipates that 70% of patients will avoid long-term toxicity and

experience excellent recurrence-free survival rates comparable to standard chemotherapy or

radiation therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed pure seminomatous testicular germ cell tumor

- Presence of iliac or retroperitoneal lymph node metastasis detected in

contrast-enhanced CT or MRI, classified as local or unilaterally regional

- Maximum extent of lymph node metastasis (LN-M) singular or multiple, with a maximum

size of 5 cm in transverse CT diameter (UICC IIB)

- Patients with an elevation in HCG after orchiectomy at the time of staging examination

can be included if the directly preoperatively determined HCG does not exceed 5 IU/L.

Patients can be included in the following scenarios:

- Initial diagnosis of a tumor in UICC stage IIA/IIB

- Recurrence of a tumor in clinical stage (CS) I under active surveillance

- Recurrence of a CS I tumor after adjuvant therapy with carboplatin mono

Exclusion Criteria:

- LN-M with a transverse diameter >5 cm in CT (UICC IIC)

- Other metastases than LN-M (UICC III)

- The patient received a different chemotherapy than described above

- The patient underwent retroperitoneal radiotherapy

- The patient is in a reduced general condition or has a life-threatening illness

- The patient has a psychiatric illness

- Evidence of non-seminomatous germ cell tumor components in the RPLND histology

- Complete resection cannot be ensured due to previous surgeries

- In the "high risk" group: Contraindications to cisplatin, etoposide, or bleomycin

(severe liver insufficiency, severe kidney insufficiency, severe lung insufficiency,

hypersensitivity, severe bone marrow depression, profound hearing impairments)

Studien-Rationale

Primary outcome:

1. Progression-free survival (Time Frame - 3 years)

Secondary outcome:

1. Overall survival (Time Frame - at least 5 years)

2. Time to progression (Time Frame - from intervention to progression assessed up to 5 years)

3. Complications (Time Frame - intra- and perioperative):
Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel, Clavien-Dindo

4. Quality of life (Time Frame - baseline and yearly, up to 5 years):
EORTC QLQ-C30 and QLQ-TC26

5. Mental health (Time Frame - baseline and yearly, up to 5 years):
Questionnaire

6. Rate of retrograde ejaculation (Time Frame - postoperative assessment yearly, up to 5 years)

7. Validation of microRNA-371 (Time Frame - Day before surgery, day 3-5 after surgery and in case of adjuvant therapy 3 days from last drug application):
Measurements of the biomarker microRNA-371

8. Analysis of molecular characteristics (Time Frame - after study recruitment completion):
Measurements still not specified

Studien-Arme

Experimental: Low risk
Criteria for "low risk": Absence of "high risk" criteria Previous carboplatin therapy post orchiectomy Exclusion of malignancy in the RPLND histology
Experimental: High risk
Criteria for "high risk": Clinical stage II at initial diagnosis Primary tumor > 4 cm Infiltration of the "rete testis" in the primary tumor

Geprüfte Regime

Robot-assisted retroperitoneal lymph node dissection:
Robot-assisted, if possibe ipsilateral nerve-sparing, retroperitoneal lymph node dissection and metastasis resection in a unilateral dissection field ("template")
Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin:
The patient is given the option for an adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin two to four weeks after RA-RPLND

Quelle: ClinicalTrials.gov

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