A randomized study in testicular cancer without metastasis, comparing two different types of chemotherapy used to reduce the risk of relapse

2024-518399-29-00 Protocol SWENOTECA Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 27 Dec 2024 · Status Authorised, recruiting · 2 EU/EEA countries · 15 sites · Protocol SWENOTECA

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 348
Countries 2
Sites 15

Testicular cancer

The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse rate compared to one course of adjuvant carboplatin AUC7.

Key facts

Sponsor
St. Olavs Hospital HF
Participant type
Patients
Age range
18-64 years
Gender
Male
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
27 Dec 2024 → ongoing
Decision date (initial)
2024-12-18
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518399-29-00
EudraCT number
2014-004075-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse rate compared to one course of adjuvant carboplatin AUC7.

Conditions and MedDRA coding

Testicular cancer

VersionLevelCodeTermSystem organ class
21.0 PT 10043350 Testicular seminoma (pure) stage I 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

  1. Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and stromal invasion of the rete testis
  2. Clinical stage I
  3. Tumor size over 4 cm and/or stromal 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 years and < 60 years
  6. ECOG performance status 0, 1 or 2
  7. 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)
  8. 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)
  9. Written informed consent

Exclusion criteria 8

  1. Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis
  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. Prior history of any cancer the last 5 years excluding basal cell carcinoma
  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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Relapse rate

Secondary endpoints 5

  1. Short-term toxicity
  2. Long-term toxicity
  3. Health related quality of life
  4. Overall survival
  5. Health economy analysis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Bleomycin

SCP111064525 · ATC

Active substance
Bleomycin
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
30000 U unit(s)
Max total dose
90000 U unit(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
L01DC01 — BLEOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SCP134220 · ATC

Active substance
Cisplatin
Substance synonyms
Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
20 mg/m2 milligram(s)/sq. meter
Max total dose
100 mg/m2 milligram(s)/sq. meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SCP100376572 · ATC

Active substance
Etoposide
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
L01CB01 — ETOPOSIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Carboplatin

SCP10337134 · ATC

Active substance
Carboplatin
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
1500 mg milligram(s)
Max total dose
1500 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St. Olavs Hospital HF

16 Total trials 6 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
St. Olavs Hospital HF
Address
Prinsesse Kristinas G. 3
City
Trondheim
Postcode
7030
Country
Norway

Scientific contact point

Organisation
St. Olavs Hospital HF
Contact name
Torgrim Tandstad

Public contact point

Organisation
St. Olavs Hospital HF
Contact name
Torgrim Tandstad

Third parties 4

OrganisationCity, countryDuties
Karolinska University Hospital
ORG-100000573
 Solna, Sweden On site monitoring
Lund University Hospital
ORG-100009989
 Lund, Sweden On site monitoring
St. Olavs Hospital HF
ORG-100030086
 Trondheim, Norway On site monitoring
Region Oestergoetland
ORG-100010599
 Linkoping, Sweden On site monitoring

Locations

2 EU/EEA countries · 15 investigational sites

By country

CountryMS statusPlanned subjectsSites
Norway Authorised, recruiting 174 5
Sweden Authorised, recruiting 174 10
Rest of world — 0 —

Investigational sites

Norway

5 sites · Authorised, recruiting
Helse Moere Og Romsdal HF
Department of Oncology, Aasehaugen 1, 6017, Aalesund
Oslo University Hospital HF
Department of Oncology, P. O. Box 4953, 0424, Oslo
Helse Bergen HF
Department of Oncology, Jonas Lies Vei 65, 5021, Bergen
Universitetssykehuset Nord-Norge HF
Department of Oncology, P. O. Box 100, 9038, Tromsoe
St. Olavs Hospital HF
Department of Oncology, Prinsesse Kristinas G. 3, 7030, Trondheim

Sweden

10 sites · Authorised, recruiting
Region Gaevleborg
Department of Oncology, Lasarettsvagen 1, 803 24, Gavle
Lund University Hospital
Department of Oncology, Getingevaegen 4, 222 42, Lund
Region Vaestmanland
Department of Oncology, Centrallasarettet 1, Vasteras Badelunda, Vasteras
Region Joenkoepings Laen
Department of Oncology, Futurum Verksamhetsnara Funktion, Lanssjukhuset Ryhov Hus B 4, Jonkoping
Region Oestergoetland
Department of Oncology, Universitetssjukhuset I, 58185, Linkoping
Region Vaesternorrland
Department of Oncology, Lasarettsvagen 21, 856 43, Sundsvall
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department of Oncology, Bla Straket 5, Goteborgs Annedal, Goteborg
Uppsala University Hospital
Department of Medicine, Dag Hammarskjolds Vag 20, Uppsala Domkyrkofors., Uppsala
Region Vaesterbotten
Department of Oncology, Umea University, 901 85, Umea
Karolinska University Hospital
Department of Oncology-Pathology, Eugeniavagen 3, 171 64, Solna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Norway 2024-12-27
Sweden 2024-12-27

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-518399-29-00 1.7
Recruitment arrangements (for publication) Placeholder_recruitment 1
Recruitment arrangements (for publication) Placeholder_recruitment 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults SE 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF adults_NO 1.1
Summary of Product Characteristics (SmPC) (for publication) SPC Bleomycin 1
Summary of Product Characteristics (SmPC) (for publication) SPC Carboplatin 1
Summary of Product Characteristics (SmPC) (for publication) SPC Cisplatin 1
Summary of Product Characteristics (SmPC) (for publication) SPC Etoposid 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EN EU CT 2024-518399-29-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_NO EU CT 2024-518399-29-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_SE EU CT 2024-518399-29-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-11-08 Norway Acceptable
2024-12-13
 2024-12-18
2 SUBSTANTIAL MODIFICATION SM-1 2025-06-16 Norway Acceptable
2025-09-05
 2025-09-08