Therapy De-escalation in Seminoma Stage IIA/B

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Swiss Group for Clinical Cancer Research
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT01593241
First received: May 1, 2012
Last updated: January 13, 2015
Last verified: January 2015
  Purpose

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 Intervention Phase
Seminoma
Drug: Carboplatin
Radiation: Involved node RT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: at 3 years (± 1 month) ] [ Designated as safety issue: No ]
    success/failure of PFS


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

  • Late AEs [ Time Frame: at the latest at 20 years ] [ Designated as safety issue: Yes ]
    AEs will be collected from 30 days after the end of treatment until the end of the follow-up phase

  • Incidence of secondary malignancies [ Time Frame: at the latest at 20 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: at the latest at 20 years ] [ Designated as safety issue: No ]
    from registration until documented progressive disease, relapse or death due to tumor.

  • Overall survival (OS) [ Time Frame: at the latest at 20 years. ] [ Designated as safety issue: No ]
    from registration to the date of death from any cause

  • Seminoma specific survival [ Time Frame: at the latest at 20 years ] [ Designated as safety issue: No ]
    from registration to the date of death due to seminoma

  • PFS [ Time Frame: at the latest at 20 years ] [ Designated as safety issue: No ]
    from registration to the date of failure of PFS

  • Localization of progression [ Time Frame: at the latest at 20 years ] [ Designated as safety issue: No ]
    from first localization where recurrent tumor disease is detected


Estimated Enrollment: 115
Study Start Date: May 2012
Estimated Study Completion Date: June 2037
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 of the chest, abdomen and pelvis or a FDG-PET-CT within 4 weeks prior to patient registration, showing stage IIA/B disease. Oral and i.v. contrast have 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593241

Contacts
Contact: Alexandros Papachristofilou, MD +41 61 265 49 46 apapachristofilou@uhbs.ch

Locations
Germany
AachenUniversitätsklinik Recruiting
Aachen, Germany, 52074
Contact: Axel Heidenreich, Prof Dr med    +49 24 180 89374    aheidenreich@ukaachen.de   
Principal Investigator: Axel Heidenreich, Prof Dr med         
Berlin Universitätsklinik Charité Recruiting
Berlin, Germany, 10117
Contact: Jonas Busch, MD    +49 30 450 515095    jonas.busch@charite.de   
Principal Investigator: Jonas Busch, MD         
Berlin Vivantes - Neukölln Recruiting
Berlin, Germany, 12351
Contact: Maike de Wit, Prof Dr    +49 30 130 142251    maike.dewit@vivantes.de   
Principal Investigator: Maike de Wit, Prof Dr         
Berlin Vivantes - Urban Recruiting
Berlin, Germany, 10967
Contact: Annette Dieing, Prof Dr med    +49 30 130 222152    annette.dieing@vivantes.de   
Principal Investigator: Annette Dieing, Prof Dr med         
Universitaetsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, D-40225
Contact: Lorch Anja, Prof    +49 211-810 8138    anja.lorch@med.uni-duesseldorf.de   
Principal Investigator: Anja Lorch, Prof         
Hamburg Universitätsklinikum - Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Karin Oechsle, PD Dr med    +49 40 741 050667    k.oechsle@uke.uni-hamburg.de   
Principal Investigator: Karin Oechsle, PD Dr med         
Krefeld Maria-Hilf Krankenhaus Recruiting
Krefeld, Germany, 47805
Contact: Susanne Krege, Prof Dr med    +49 21 513 342381    susanne.krege@alexianer-krefeld.de   
Principal Investigator: Susanne Krege, Prof Dr med         
Klinikum Harlaching Recruiting
München, Germany, 81545
Contact: Markus Hentrich, Prof    +49 89 6210-2663    marcus.hentrich@klinikum-muenchen.de   
Principal Investigator: Markus Hentrich, Prof         
Switzerland
Kantonspital Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: Philippe von Burg, MD    +41 62 838 59 94    philippe.vonburg@ksa.ch   
Principal Investigator: Philippe von Burg, MD         
Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Contact: Tammo Bartnick, MD    +41 56 486 27 62    tammo.bartnick@ksb.ch   
Principal Investigator: Tammo Bartnick, MD         
Universitaetsspital-Basel Recruiting
Basel, Switzerland, 4031
Contact: Alexandros Papachristofilou, MD    +41 61 265 49 46    apapachristofilou@uhbs.ch   
Principal Investigator: Alexandros Papachristofilou, MD         
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli Recruiting
Bellinzona, Switzerland, 6500
Contact: Gianfranco Pesce, MD    +41 91 811 86 73    GianfrancoAngelo.Pesce@eoc.ch   
Principal Investigator: Gianfranco A. Pesce, MD         
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Daniel Aebersold, Prof Dr med    +41 (0)31 632 24 31    daniel.aebersold@insel.ch   
Principal Investigator: Daniel Aebersold, Prof Dr med         
Spitalzentrum Biel Recruiting
Biel, Switzerland, CH-2501
Contact: Karl Beer, MD    +41 (0)31 632 24 31    daniel.aebersold@insel.ch   
Principal Investigator: Daniel Aebersold, Prof Dr med         
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, 7000
Contact: Richard Cathomas, MD    +41 81 256 66 95    richard.cathomas@ksgr.ch   
Principal Investigator: Richard Cathomas, MD         
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Grégoire Berthod, MD    +41 21 314 01 55    Gregoire.berthod@chuv.ch   
Principal Investigator: Grégoire Berthod, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland, CH-4600
Contact: Walter Mingrone, MD    41-62-311-4241    wmingrone_ol@spital.ktso.ch   
Principal Investigator: Walter Mingrone, MD         
Hopital de Sion Recruiting
Sion, Switzerland, 1951
Contact: Kaouthar Kanfir    41-27-603-8772    kaouthar.khanfir@rsv-gnw.ch   
Principal Investigator: Kaouthar Kanfir         
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Ludwig Plasswilm, PD Dr.    41-71-494-2232    ludwig.plasswilm@kssg.ch   
Principal Investigator: Ludwig Plasswilm, PD Dr. med.         
Regionalspital Thun Recruiting
Thun, Switzerland, 3600
Contact: Daniel Aebersold, Prof Dr med    +41 (0)31 632 24 31    daniel.aebersold@insel.ch   
Principal Investigator: Daniel Aebersold, Prof Dr med         
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Contact Person    41-052-266-40-87    natalie.fischer@ksw.ch   
Principal Investigator: Natalie Fischer, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT01593241     History of Changes
Other Study ID Numbers: SAKK 01/10, 34569, 2011-005840-87
Study First Received: May 1, 2012
Last Updated: January 13, 2015
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Seminoma
Germinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Carboplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 25, 2015