Status:
UNKNOWN
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)
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Stage II A/B Seminomatous Germ Cell Tumors
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
Primary objective: to evaluate progression-free survival in patients with clinical stage II A/B seminomatous germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without a...
Detailed Description
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 node...
Eligibility Criteria
Inclusion
- histologically confirmed seminomatous testicular germ cell tumor
- 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
- initial diagnosis of UICC clinical stage IIA/IIB disease
- recurrence after surveillance for clinical stage I
- 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
- 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
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02797626
Start Date
June 1 2016
End Date
June 1 2021
Last Update
June 13 2016
Active Locations (1)
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1
Departement of Urology, Heinrich Heine University Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225