Therapy De-escalation in Seminoma Stage IIA/B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01593241
Recruitment Status : Recruiting
First Posted : May 8, 2012
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
The main objective of this trial is to test the efficacy and safety of carboplatin chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.

Condition or disease Intervention/treatment Phase
Seminoma Drug: Carboplatin Radiation: Involved node RT Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma
Actual Study Start Date : June 15, 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2038

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: Carboplatin Drug: Carboplatin
Stage IIA: 1 infusion Carboplatin AUC7 followed by 15 x 2 Gy involved node radiotherapy Stage IIB: 1 infusion Carboplatin AUC7 followed by 18 x 2 Gy involved node radiotherapy

Radiation: Involved node RT
Involved node RT

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: at 3 years ]

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

    • PD 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 over the ULN (value must be confirmed by a second measurement). Presence of non-seminoma germ cell tumor has to be excluded in the latter case.
    • Death from any cause.

Secondary Outcome Measures :
  1. Adverse events (AEs) temporarily associated with the trial treatment [ Time Frame: at 3 years ]
    AEs are collected from inclusion until 30 days after the end of treatment

  2. Late AEs [ Time Frame: at the latest at 20 years ]
    AEs will be collected from 30 days after the end of treatment until the end of the follow-up phase

  3. Incidence of secondary malignancies [ Time Frame: at the latest at 20 years ]
  4. Response rate [ Time Frame: at 3 years ]
  5. Time to progression (TTP) [ Time Frame: at the latest at 20 years ]
    from registration until documented progressive disease, relapse or death due to tumor.

  6. Overall survival (OS) [ Time Frame: at the latest at 20 years. ]
    from registration to the date of death from any cause

  7. Seminoma specific survival [ Time Frame: at the latest at 20 years ]
    from registration to the date of death due to seminoma

  8. PFS [ Time Frame: at the latest at 20 years ]
    from registration to the date of failure of PFS

  9. Localization of progression [ Time Frame: at the latest at 20 years ]
    from first localization where recurrent tumor disease is detected

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has given written informed consent before registration.
  • Histologically confirmed classical seminoma treated with primary inguinal orchidectomy.
  • Tumor stage at diagnosis or at relapse after primary active surveillance is pT1-4* cN1-2 cM0 according to UICC TNM 2009 is pT1-4 cN1-2 cM0 according to UICC TNM 2009.
  • Multi-slice CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis or a FDG-PET-CT within 4 weeks prior to patient registration, showing stage IIA/B disease. I.v. contrast medium has to be administered.
  • Age ≥ 18 years.
  • WHO performance status 0-2.
  • Adequate hematological values: neutrophils ≥ 1.0 x 109/L, platelets ≥ 100x 109/L.
  • Adequate renal function (calculated creatinine clearance ≥ 50 ml/min, according to the formula of Cockcroft-Gault).
  • Patient agrees not to father a child during trial treatment and during 12 months thereafter.
  • Patient has been proposed sperm conservation.
  • Patient compliance and geographic proximity allow proper staging and follow-up for at least 3 years.

Exclusion Criteria:

  • Previous or concurrent malignancy within 5 years with the exception of localized non-melanoma skin cancer or stage I seminoma for patients entering the trial with relapse during active surveillance.
  • Psychiatric disorder precluding understanding of information on trial-related topics or giving informed consent or interfering with compliance for treatment schedule.
  • Mixed histology seminoma.
  • Elevated levels of AFP (≥ULN) at any time.
  • Any prior abdominal/pelvic radiotherapy (RT).
  • Any anti-cancer therapy after primary tumor resection (active surveillance for stage I disease is not considered as a treatment).
  • Any treatment in a clinical trial within 30 days of trial entry.
  • Any serious underlying medical condition or serious co-morbidity (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial.
  • Any contraindication for the trial drug (for example, known hypersensitivity to trial drug or to any other co-component of the trial drug, past or current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects).
  • Any concomitant drugs contraindicated for use with the trial drug according to the approved product information (for example, nephrotoxic or ototoxic medicines).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01593241

Contact: Alexandros Papachristofilou, MD +41 61 265 49 46
Contact: Corinne Schär, PhD +41 31 389 91 91

Aachen Universitätsklinik Withdrawn
Aachen, Germany, 52074
Berlin Universitätsklinik Charité Recruiting
Berlin, Germany, 10117
Contact: Jonas Busch, MD    +49 30 450 515095   
Principal Investigator: Jonas Busch, MD         
Berlin Vivantes - Urban Recruiting
Berlin, Germany, 10967
Contact: Annette Dieing, Prof    +49 30 130 222152   
Principal Investigator: Annette Dieing, Prof         
Berlin Vivantes - Neukölln Recruiting
Berlin, Germany, 12351
Contact: Maike de Wit, Prof    +49 30 130 142251   
Principal Investigator: Maike de Wit, Prof         
Universitaetsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, D-40225
Contact: Lorch Anja, Prof    +49 211 810 8138   
Principal Investigator: Anja Lorch, Prof         
Klinik Essen-Mitte Recruiting
Essen, Germany, 45136
Contact: Susanne Krege, Prof    +49 201 174 29 003   
Principal Investigator: Susanne Krege, Prof         
Hamburg Universitätsklinikum - Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Karin Oechsle, MD    +49 40 741 050667   
Principal Investigator: Karin Oechsle, MD         
Krefeld Maria-Hilf Krankenhaus Active, not recruiting
Krefeld, Germany, 47805
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Contact: Jan Herden, MD    +49 221 478 82112   
Principal Investigator: Jan Herden, MD         
Klinikum Harlaching Recruiting
München, Germany, 81545
Contact: Xaver Schiel, Prof    +49 89 6210 2731   
Principal Investigator: Xaver Schiel, Prof         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Jens Bedke, Prof    +49 (7071) 2980349   
Principal Investigator: Jens Bedke, Prof         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact: Friedemann Zengerling, MD    +49 731 500 58036   
Principal Investigator: Friedemann Zengerling, MD         
Kantonspital Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: Tobias Wehrhahn, MD    +41 62 838 59 27   
Principal Investigator: Tobias Wehrhahn, MD         
Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Contact: Tammo Bartnick, MD    +41 56 486 27 62   
Principal Investigator: Tammo Bartnick, MD         
Universitaetsspital-Basel Recruiting
Basel, Switzerland, 4031
Contact: Alexandros Papachristofilou, MD    +41 61 265 49 46   
Principal Investigator: Alexandros Papachristofilou, MD         
Istituto Oncologico della Svizzera Italiana (IOSI) Recruiting
Bellinzona, Switzerland, CH-6500
Contact: Ngwa Che Azinwi, MD    +41 91 811 89 32   
Principal Investigator: Ngwa Che Azinwi, MD         
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Daniel Aebersold, Prof    +41 31 632 24 31   
Principal Investigator: Daniel Aebersold, Prof         
Spitalzentrum Biel Recruiting
Biel, Switzerland, CH-2501
Contact: Daniel Aebersold, MD    +41 31 632 24 31   
Principal Investigator: Daniel Aebersold, MD         
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, 7000
Contact: Richard Cathomas, MD    +41 81 256 66 95   
Principal Investigator: Richard Cathomas, MD         
Centre Hospitalier Universitaire Vaudois CHUV Recruiting
Lausanne, Switzerland, CH-1011
Contact: Dominik Berthold, MD    +41 21 314 80 83   
Principal Investigator: Dominik Berthold, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland, CH-4600
Contact: Walter Mingrone, MD    +41 62 311 42 41   
Principal Investigator: Walter Mingrone, MD         
Hopital de Sion Recruiting
Sion, Switzerland, 1951
Contact: Kaouthar Khanfir, MD    +41 27 603 87 72   
Principal Investigator: Kaouthar Khanfir, MD         
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Ludwig Plasswilm, MD    +41 71 494 22 32   
Principal Investigator: Ludwig Plasswilm, MD         
Regionalspital Thun Recruiting
Thun, Switzerland, 3600
Contact: Daniel Aebersold, Prof    +41 31 632 24 31   
Principal Investigator: Daniel Aebersold, Prof         
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Natalie Fischer, MD    +41 52 266 40 87   
Principal Investigator: Natalie Fischer, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Alexandros Papachristofilou, MD University Hospital, Basel, Switzerland
Study Chair: Richard Cathomas, MD Cantonal Hospital Graubünden
Study Chair: Jens Bedke, Prof D - University Hospital Tübingen

Additional Information:
Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT01593241     History of Changes
Other Study ID Numbers: SAKK 01/10
34569 ( Other Identifier: SNCTP )
2011-005840-87 ( EudraCT Number )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Group for Clinical Cancer Research:
Seminoma IIA/B

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Antineoplastic Agents