Clinical trial • Phase III • Oncology
ETOPOSIDE for Testicular seminoma (stage I) | Testicular cancer
Phase III trial of ETOPOSIDE for Testicular seminoma (stage I) | Testicular cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Testicular seminoma (stage I) | Testicular cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-11-2024
- First CTIS Authorization Date
- 18-12-2024
Trial design
Randomised, carboplatin auc7, one course (comparator arm); adjuvant bep (bleomycin + etoposide + cisplatin), one course (experimental arm)-controlled Phase III trial across 15 sites in Sweden, Norway.
- Randomised
- Yes
- Comparator
- Carboplatin AUC7, one course (comparator arm); Adjuvant BEP (Bleomycin + Etoposide + Cisplatin), one course (experimental arm)
- Target Sample Size
- 348
Eligibility
Recruits 348 No vulnerable populations selected; written informed consent is required from participants. Subject information and informed consent forms provided for adults (L1_SIS and ICF adults SE and L1_SIS and ICF adults_NO)..
- Vulnerable Population
- No vulnerable populations selected; written informed consent is required from participants. Subject information and informed consent forms provided for adults (L1_SIS and ICF adults SE and L1_SIS and ICF adults_NO).
Inclusion criteria
- {"criterion_text":"- Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and stromal invasion of the rete testis\n- Clinical stage I\n- Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells\n- Normal value of AFP before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted\n- Age ≥ 18 years and < 60 years\n- ECOG performance status 0, 1 or 2\n- Adequate organ function defined as: a. Serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). b. Total serum bilirubin ≤ 1.5 x ULN c. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L d. Platelets ≥ 100 x 109/L e. GFR > 50 ml/min (see below for allowed methods of analysis)\n- All fertile patients should use safe contraception 6 months following adjuvant treatment (Patient: Condom (Sweden only) or sterilisation or Partner: combination hormonal contraceptive, sterilisation or intrauterine device)\n- Written informed consent"}
Exclusion criteria
- {"criterion_text":"- Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis\n- Prior diagnosis of testicular cancer\n- Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)\n- Prior history of any cancer the last 5 years excluding basal cell carcinoma\n- Known hypersensitivity or contraindications for the study drugs\n- 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\n- Conditions – medical, social, psychological – which could prevent adequate information and follow-up\n- Medication interacting with the study drugs"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Relapse rate","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Short-term toxicity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Long-term toxicity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Health related quality of life","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
- {"endpoint_text":"- Health economy analysis","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 348
- Recruitment Window Months
- 212
- Consent Approach
- Written informed consent required from participants; adult subject information and informed consent forms provided (documents: L1_SIS and ICF adults SE, L1_SIS and ICF adults_NO) in Swedish and Norwegian.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 348
Sweden
- Earliest CTIS Part Ii Submission Date
- 11-12-2024
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 271
- Number Of Sites
- 10
- Number Of Participants
- 174
Sites
- Site Name
- Region Vaesterbotten
- Department Name
- Department of Oncology
- Contact Person Name
- Martin Hellström
- Contact Person Email
- martin.hellstrom@regionvasterbotten.se
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Oncology-Pathology
- Contact Person Name
- Gabriella Cohn Cedermark
- Contact Person Email
- gabriella.cohn-cedermark@regionstockholm.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Oncology
- Contact Person Name
- Annika Hedlund
- Contact Person Email
- annika.hedlund@vregion.se
- Site Name
- Region Vaesternorrland
- Department Name
- Department of Oncology
- Contact Person Name
- Elin Jänes
- Contact Person Email
- elin.janes@lvn.se
- Site Name
- Lund University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Olof Ståhl
- Contact Person Email
- olof.stahl@med.lu.se
- Site Name
- Uppsala University Hospital
- Department Name
- Department of Medicine
- Contact Person Name
- Ingrid Glimelius
- Contact Person Email
- ingrid.glimelius@onkologi.uu.se
- Site Name
- Region Vaestmanland
- Department Name
- Department of Oncology
- Contact Person Name
- Martin Bruzelius
- Contact Person Email
- martin.bruzelius@regionvastmanland.se
- Site Name
- Region Gaevleborg
- Department Name
- Department of Oncology
- Contact Person Name
- Sattar Zebary
- Contact Person Email
- Sattar.zebary@regiongavleborg.se
- Site Name
- Region Oestergoetland
- Department Name
- Department of Oncology
- Contact Person Name
- Malin Huss
- Contact Person Email
- Malin.Huss@regionostergotland.se
- Site Name
- Region Joenkoepings Laen
- Department Name
- Department of Oncology
- Contact Person Name
- Linn Pettersson
- Contact Person Email
- linn.pettersson@lvn.se
Norway
- Earliest CTIS Part Ii Submission Date
- 28-11-2024
- Latest Decision Or Authorization Date
- 10-09-2025
- Processing Time Days
- 286
- Number Of Sites
- 5
- Number Of Participants
- 174
Sites
- Site Name
- Helse Moere Og Romsdal HF
- Department Name
- Department of Oncology
- Contact Person Name
- Øyvind Kvammen
- Contact Person Email
- oivind.kvammen@helse-mr.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Oncology
- Contact Person Name
- Helene Francisca Stigter Negaard
- Contact Person Email
- uxhega@ous-hf.no
- Site Name
- Helse Bergen HF
- Department Name
- Department of Oncology
- Contact Person Name
- Åsa Karlsdottir
- Contact Person Email
- asa.karlsdottir@helse-bergen.no
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Department of Oncology
- Contact Person Name
- Hege Sagstuen Haugnes
- Contact Person Email
- hege.sagstuen.haugnes@unn.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Department of Oncology
- Contact Person Name
- Torgrim Tandstad
- Contact Person Email
- torgrim.tandstad@stolav.no
Sponsor
Primary sponsor
- Full Name
- St. Olavs Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Third parties
- {"country":"Sweden","full_name":"Karolinska University Hospital","duties_or_roles":"code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Sweden","full_name":"Lund University Hospital","duties_or_roles":"code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Norway","full_name":"St. Olavs Hospital HF","duties_or_roles":"code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Sweden","full_name":"Region Oestergoetland","duties_or_roles":"code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous administration
- Maximum Dose
- 500 mg/m2
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous administration
- Maximum Dose
- 100 mg/m2
- Investigational Product Name
- BLEOMYCIN
- Active Substance
- BLEOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous administration
- Maximum Dose
- 90000 U
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous administration
- Maximum Dose
- 1500 mg
- Combination Treatment
- Yes
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