PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
ConditionSeminoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-99
SponsorHeinrich-Heine University, Duesseldorf
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Robot-assisted retroperitoneal lymph node dissection
- Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov