AzTrials
AzTrials

SeminomaPhase 2NCT03937843

Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma

A Phase 2 study testing Carboplatin, Cisplatin and Etoposide in people with Seminoma and Testicular Cancer, run by Swiss Cancer Institute at 19 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The trial investigates a stage-adapted (stage IIA or IIB) de-escalation of the standard treatments in the context of a multimodality treatment with chemo- and radiotherapy in seminoma patients. The goal is to safely de-escalate treatment while maintaining/enhancing efficacy, which is not a standard practice yet. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Seminoma, Testicular Cancer
What is being tested?
Carboplatin, Cisplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
19 sitesin 2 countries
Study dates
29 Jul 2019to 31 Dec 2046
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent according to ICH/GCP (International Council on Harmonization/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
  • Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
  • Patients with a seminoma stage IIA or IIB, either newly diagnosed or recurrent after primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease. The tumor stage is pT1-4 cN1-2 cM0 according to UICC TNM 8th edition 2016. Patients with a recurrent seminoma stage IIA or IIB are only eligible in case of progression under active surveillance or recurrence after adjuvant carboplatin or radiotherapy for stage I disease
  • Stage IIA, in patients with equivocal lymph node enlargement, needs to be confirmed with a repeated CT/MRI scan of the abdomen (suggested timeframe: 4 weeks after the previous scan) in order to rule out false positive lymph node enlargement.
  • Patients with a prior malignancy treated with curative intention are eligible if all treatment of that malignancy was completed at least 5 years before registration and the patient has no evidence of disease at registration. Less than 5 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence. Patients with a germ cell neoplasia in situ (GCNIS) or contralateral localized treated seminoma are eligible
  • Diagnostic CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis within 28 days prior to registration, showing stage IIA/B disease. I.v. contrast medium has to be administered
Show all 12Show fewer
  • Age ≥ 18 years
  • WHO performance status 0-2
  • Baseline PRO questionnaires have been completed
  • Adequate bone marrow function: neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100x 109/L
  • Adequate renal function: creatinine clearance ≥ 60 ml/min calculated according to the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
  • Patient agrees to use highly effective contraception and not to donate sperm or to father a child during trial treatment and during 12 months thereafter. Patient has been proposed sperm conservation.

Who cannot join

  • Any other histological component than seminoma
  • Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)
  • Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
  • Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
  • Any serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator's judgment)
  • Any treatment in a clinical trial within 28 days prior to registration
Show all 12Show fewer
  • Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy
  • Known hypersensitivity to trial drugs or to any component of the trial drugs
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
  • Additional German specific exclusion criteria - not to be considered for Swiss patients
  • Patient who is dependent on the sponsor or the investigators according to ICH/GCP E6(R2), guideline
  • Patient who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities according to § 40a (2) AMG.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Switzerland10 sites

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Istituto Oncologico della Svizzera Italiana (IOSI)

    Bellinzona, CH-6500

  • Inselspital Bern

    Bern, 3010

  • Kantonsspital Graubuenden

    Chur, 7000

  • Kantonsspital Graubünden

    Chur, 7000

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, CH-1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Hopital de Sion

    Sion, 1951

  • Kantonsspital Winterthur

    Winterthur, 8401

  • UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

Germany9 sites

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Evang. Kliniken Essen-Mitte

    Essen, 45136

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • ASKLEPIOS Kliniken

    Hamburg, 22763

  • RKH Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • Rotkreuzklinikum München

    München, München, 80364

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89075

Other trials in Germany

About this study

Official title: Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma. A Multicenter, Open Label Phase II Trial With Two Cohorts

The trial investigates a stage-adapted (stage IIA or IIB) de-escalation of the standard treatments in the context of a multimodality treatment with chemo- and radiotherapy in seminoma patients. The goal is to safely de-escalate treatment while maintaining/enhancing efficacy, which is not a standard practice yet.

Read the detailed description

Therapy de-escalation in stage IIA/B seminoma represents an unmet need in clinical practice; efficacy of modern standard of care therapies for these patients is high and only a few patients show disease recurrence but short- and long-term toxicities are a major concern. The magnitude of long-term toxicities is often associated with the intensity of the prescribed treatment modality. A higher cumulative dose of chemotherapy agents and radiation dose has been linked to a sharp increase in long-term sequelae. Combining treatment modalities and diversifying toxicity may thus provide an opportunity to limit long-term treatment sequelae.

In this trial carboplatin, cisplatin and etoposide are the Investigational Medicine Products (IMPs). They are all medications with a marketing authorization for several solid tumor types and are standard practice in the treatment of testicular cancer in Switzerland and in the European Union (EU).

Radiotherapy is also a standard therapy in this indication.

However, the trial investigates a stage-adapted (stage IIA or IIB) de-escalation of these standard treatments in the context of a multimodality treatment with chemo- and radiotherapy. The goal is to safely de-escalate treatment while maintaining/enhancing efficacy, which is not a standard practice yet.

The SAKK 01/18 trial is designed with the aim to answer these three questions:

  • Can the dose of involved-node radiotherapy be safely reduced in the context of multimodality treatment with chemo- and radiotherapy?
  • Can a more potent chemotherapy in the form of cisplatin/etoposide reduce the rate of distant failure in comparison to carboplatin?
  • Can a combination of cisplatin/etoposide and involved-node radiotherapy pose a potent treatment regime for patients with recurrence after adjuvant carboplatin or radiotherapy for stage I seminoma? Furthermore, as active surveillance is becoming standard of care in stage I seminoma, it is projected that the amount of patients in need of treatment with stage IIA/B disease will rise, due to more patients developing disease progression during active surveillance.

The trial design, trial treatment and trial specifics are a consensus among the Swiss Urogenital Tumors Project Group and the Swiss Radio-oncology Section from the Swiss Group for Clinical Cancer Research (SAKK) and the German Testicular Cancer Study Group (GTCSG).

Keywords
Seminoma, Stage IIA/B seminoma, Radio-chemotherapy, Phase II trial, Testicular Cancer
Medical subject headings
Seminoma, Testicular Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Patients in cohort 1 will receive a 60-minute i.v. infusion of carboplatin AUC 7 at day 1 of treatment.

  • CisplatinDrug

    Patients in cohort 2 will receive on day 1 to day 5:

    • a 60-minutes i.v. infusion of etoposide 100mg/m2 per day followed by
    • a 60-120 minutes i.v. infusion of cisplatin 20mg/m2 per day.

  • EtoposideDrug

    Patients in cohort 2 will receive on day 1 to day 5:

    • a 60-minutes i.v. infusion of etoposide 100mg/m2 per day followed by
    • a 60-120 minutes i.v. infusion of cisplatin 20mg/m2 per day.
Study groups in NCT03937843
Study groupRoleWhat they receive
Arm with 2 cohortsExperimentalCohort 1: Primary stage IIA and recurrent stage IIA seminoma after active surveillance for stage I: * Within 7 days after registration, the patients will receive one infusion of carboplatin AUC (Area under the curve) 7 at day 1 of trial treatment, followed 3 weeks later by 12 x 2 Gy involved-node radiation therapy (RT). RT should ideally start on day 22 (range: day 19-25) from the date of carboplatin administration, preferably on a Monday. Cohort 2: Primary stage IIB and recurrent stage IIB seminoma after active surveillance for stage I OR stage IIA/B seminoma after adjuvant carboplatin or radiotherapy for stage I: * Within 7 days after registration, the patients will receive one cycle of etoposide 100 mg/m2/d + cisplatin 20 mg/m2/d at days 1 to 5 of trial treatment, followed 3 weeks later by 15 x 2 Gy involved-node radiation therapy. RT should ideally start on day 22 (range: day 19-25) from the date of chemotherapy start, preferably on a Monday.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) at 3 years

    PFS is defined as the time from registration until one of the following events occurs:

    • Progressive disease or relapse, defined as progression according to the modified trial-specific version of RECIST 1.1 or a rising level of the tumor marker beta-hCG (beta human chorionic gonadotropin) over the ULN (Upper limit of normal), confirmed by a second measurement. Presence of non-seminoma germ cell tumor has to be excluded in the latter case
    • Death from any cause.

    Measured: From the date of registration until the date of progressive disease, relapse or death, whichever occurs first, assessed up to 3 years after registration

Secondary outcomes (9)

  1. Response rate (RR)

    The response is categorized according to the modified trial-specific version of RECIST 1.1 measurability criteria as: complete remission (CR), partial remission (PR), stable disease (SD), progressive disease (PD).

    The response rate is defined as proportion of patients with CR or PR on imaging assessment and without rising beta-hCG. Patients with CR, PR and SD on imaging assessment, but with confirmed rising beta-hCG will not be counted as responders, if the presence on non-seminoma germ cell tumor was excluded. Response rate will be evaluated at 3 months and 3 years after registration.

    Measured: at 3 months and 3 years after registration

  2. Progression free survival (PFS)

    Measured: From the date of registration until the date of progressive disease, relapse or death, whichever occurs first, assessed up to 20 years after registration

  3. Time to progression (TTP)

    TTP is defined as the time from registration until documented PD or relapse according to the modified trial-specific version of RECIST 1.1 or death due to progression, whichever occurs first.

    Patients without an event at the time of analysis and patients starting a new anticancer therapy in the absence of an event will be censored at the date of the last tumor assessment showing non-progression before the start of a new therapy, if any.

    Measured: From the date of registration until the date of progressive disease, relapse or death due to progression, whichever occurs first, assessed up to 20 years after registration

  4. Overall Survival (OS)

    OS is defined as the time from registration to the date of death from any cause. Patients who did not experience an event will be censored at the last known time they were known to be alive.

    Measured: From the date of registration until the date of death from any cause, assessed up to 20 years after registration

  5. Seminoma-specific survival

    Seminoma-specific survival is defined as the time from registration to the date of death due to seminoma. Patients who did not experience an event will be censored at the last known time they were known to be alive.

    Measured: From the date of registration until the date of death due to seminoma, assessed up to 20 years after registration

  6. Time to distant metastasis

    Time to distant metastasis is defined as the time from registration until first occurrence of distant metastasis. Patients not experiencing an event will be censored at the date of the last available assessment.

    Measured: From the date of registration until the date of first occurrence of distant metastasis, assessed up to 20 years after registration

  7. Time to next treatment

    Time to next treatment is defined as the time from registration to the start of any new anticancer therapy for progressive seminoma. Patients not receiving any new treatment are censored at the last date they were known to be alive.

    Measured: From the date of registration until the date of start of any new anticancer therapy for progressive seminoma, assessed up to 20 years after registration

  8. Localization of progression

    The localization of progression is defined as the first localization where progressive disease is detected. It is divided into the following sites:

    • Initially involved lymph node area
    • Non-initially involved paraaortic \& pelvic lymph node area
    • Supradiaphragmatic lymph node area
    • Organ involvement (lung, liver, bones, etc.)
    • Multiple sites simultaneously

    Measured: at the date of the first occurrence of progressive disease, assessed from registration up to 20 years after registration

  9. Method of detection of progression

    The method of detection of progression is defined as the first method used to detect the first progression event and comprises the following categories:

    • Physical examination (inspection, palpation, etc.)
    • Rising beta-hCG tumor marker
    • CT imaging
    • Ultrasound imaging
    • X-ray imaging
    • Other imaging (e. g. MRI, PET-CT)

    Measured: at the date of the first occurrence of progressive disease, assessed from registration up to 20 years after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start29 Jul 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2046 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A multicenter, open label phase II trial with two cohorts
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937843
Sponsor's protocol ID
SAKK 01/18
Other IDs
2019-000514-11, 2019
Status last verified
Jan 2026
First submitted
29 Apr 2019
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cisplatin and Etoposide in people with Seminoma and Testicular Cancer, run by Swiss Cancer Institute at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) at 3 years (time frame: From the date of registration until the date of progressive disease, relapse or death, whichever occurs first, assessed up to 3 years after registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in