Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2008
INTERVENTION: Day 1: etoposide (165 mg/m^2)/cisplatin (50 mg/m^2) (intravenous [IV] infusions) Day 2: etoposide (165 mg/m^2)/cisplatin (50 mg/m^2)/bleomycin (30,000 units) (IV infusions) Day 3: etoposide (165 mg/m^2) Day 4: granulocyte colony‐stimulating factor (G‐CSF) injection (6 mg) Day 6, 7 or 8: bleomycin (30,000 units) (IV infusion) Day 10, 11 or 12: bleomycin (30,000 units) (IV infusion) This is a single armed trial. Patients are followed‐up according to institutional practice, however, the study requires computed tomography (CT), audiometry and lung function tests to be performed at one and two years post‐chemotherapy. CONDITION: Metastatic germ cell tumour ; Cancer ; Malignant neoplasm of other and ill‐defined sites PRIMARY OUTCOME: The primary endpoint of feasibility will be judged by the results of all of the data via a risk‐benefit analysis.; ; Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE) version 3.0 criteria during treatment, and then via CR51‐EDTA for renal function (pre‐treatment versus post‐treatment). Audiometry and lung function tests (pulmonary vital capacity and diffusing capacity of the lung for carbon monoxide [DLCO]) are standard assessments performed. There is also a clinical assessment of neurotoxicity (including two‐point discrimination, Romberg test, tendon reflexes and vibration test, along with NCI CTC neuropathy‐motor toxicity and neuro‐sensory toxicity assessments). ; ; The patients are also given a simple questionnaire regarding tingling, burning and weakness they have experienced; its location, frequency and impact. SECONDARY OUTCOME: 1. To establish the response rate to this treatment; 2. To establish progression free survival INCLUSION CRITERIA: Patients must fulfill all of the following criteria in a particular category: 1. Non‐seminoma germ cell tumour (intermediate risk): 1.1. Testis or retroperitoneal primary 1.2. Abnormal markers as below: 1.2.1. Alpha‐fetoprotein (AFP) greater than 1,000 and less than 10,000 ng/ml 1.2.2. Human chorionic gonadotropin (HCG) greater than 5,000 and less than 50,000 iu/l 1.2.3. Lactate dehydrogenase (LDH) greater than 1.5 x to less than 10 x the upper limit of normal 1.3. No liver, bone, brain or other non‐pulmonary visceral metastasis 1.4. Histological confirmation of non‐seminomatous germ cell tumours (NSGCT) is not required if AFP or HCG are grossly elevated 2. Non‐seminoma germ cell tumour (poor prognosis): 2.1. Mediastinal primary, or 2.2. Non‐pulmonary visceral metastases, or 2.3. Poor markers ‐ any of AFP greater than 10,000 ng/ml, HCG greater than 50,000 iu/l, LDH greater than 10 x upper limit of normal 2.4. Histologic
Epistemonikos ID: 2a4144b5a10d9c763661f8c85615548ae6796c3a
First added on: Aug 21, 2024