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New treatment option for Seminoma
Official title PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
ClinicalTrials.gov ID: NCT06144736
What this study is testing
What is Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin?
Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin is an investigational medicine, being studied as a potential treatment for seminoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, men only
You may be able to join if
- 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...
- Initial diagnosis of a tumor in UICC stage IIA/IIB
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Düsseldorf, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Düsseldorf, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.