RecruitingPhase 2NCT06144736

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

PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A/B Seminoma Treated With RA-RPLND

Sponsor

Heinrich-Heine University, Duesseldorf

Enrollment

60 participants

Start Date

Aug 28, 2023

Study Type

INTERVENTIONAL

Conditions

Seminoma

Summary

PRIMETEST II is an interventional study involving low-volume metastatic seminoma. It explores a novel approach using robot-assisted primary retroperitoneal lymph node dissection, aiming to reduce long-term side effects and improve quality of life. By identifying factors predicting cancer recurrence, the study hopes to tailor treatments for better outcomes. The approach could potentially spare patients from chemotherapy induced long-term side effects while maintaining excellent survival rates, presenting a promising shift in testicular cancer care for this specific patient group.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 99 Years

Inclusion Criteria8

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 Criteria9

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)

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Interventions

PROCEDURERobot-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")

DRUGAdjuvant 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