A Randomized Phase III Study Comparing One Course of Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) and One Course of Carboplatin AUC7 in Clinical Stage I Seminomatous Testicular Cancer
- Conditions
- Stage I, Seminomatous, Testicular cancer.MedDRA version: 17.1Level: HLTClassification code 10043322Term: Testicular neoplasms malignantSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2014-004075-23-SE
- Lead Sponsor
- St Olavs University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 348
1. Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and invasion of the rete testis
2. Clinical stage I
3. Tumor size over 4 cm and/or invasion of the rete testis by tumor cells
4. Normal value of AFP before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted.
5. Age 18 - 60 years.
6. ECOG performance status 0, 1 or 2.
7. Adequate organ function defined as:
- Serum aspartate transaminase (ALT) = 1.5 x upper limit of normal (ULN).
- Total serum bilirubin = 1.5 x ULN
- Absolute neutrophil count (ANC) = 1.5 x 109/L
- Platelets = 100 x 109/L
- Creatinine clearance > 50 ml/min (eGFR)
8. All fertile patients should use safe contraception
9. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 348
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
2. Prior diagnosis of testicular cancer
3. Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)
4. Cancer other than seminoma testicular cancer
5. Known hypersensitivity or contraindications for the study drugs
6. Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient’s ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
7. Conditions – medical, social, psychological – which could prevent adequate information and follow-up.
8. Medication interacting with the study drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The overall aim is to investigate whether one course of adjuvant BEP (bleomycin, etoposide and cisplatin) has a lower relapse rate than one course of adjuvant carboplatin AUC7.;Secondary Objective: Furthermore, we will investigate if there is a difference in health related quality of life as well as acute and long-term toxicities from treatment.;Primary end point(s): Relapse rate.;Timepoint(s) of evaluation of this end point: Measured from the date of randomization to the first date of objective relapse of disease (according to RECIST 1.1) or of death from any cause.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Short term toxicity<br>Long-term toxicity<br>Health related quality of life<br>Overall survival<br>;Timepoint(s) of evaluation of this end point: Toxicity and health related quality of life will be evalated at different timepoints spesified in the protocol.