Content - SAKK 01/10

SAKK 01/10 - Novel combination treatment of radiotherapy and chemotherapy in attenuated form for patients with stage IIA/B seminoma

Seminoma is the most common malignant testicular tumour in young men; stage IIA/B is characterized by subdiaphragmatic lymph node metastases measuring up to 5 cm in diameter.

Standard treatment in this stage is large-volume radiotherapy of the lymph node regions below the diaphragm or several cycles of intensive chemotherapy with 3 different medicines. However, both treatments also carry risks for these young and usually otherwise healthy patients.

The prospects for a cure with standard treatment are high and can be hardly improved upon. Future research should therefore focus mainly on the means for avoiding and reducing the side effects of therapy. The aim of the study is to establish whether combination therapy made up of attenuated chemotherapy and radiotherapy is effective and associated with few side effects.

Study Chairs:

Dr. med. Alexandros Papachristofilou, University Hospital Basel, +41 61 265 49 46

Dr. med. Richard Cathomas, Cantonal Hospital Graubünden, +41 81 256 66 95

  • Contacts at the hospitals

  • 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).

Locations for this trial:

Kantonsspital Aarau
Tellstrasse 25
0 5001 Aarau
Kantonsspital Baden
Im Ergel 1
4600 Baden
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Istituto Oncologico della Svizzera Italiana IOSI
Via Ospedale
0 6500 Bellinzona
Freiburgstrasse 8
3010 Bern
Spitalzentrum Biel
Vogelsang 84
0 2501 Biel
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Centre Hospitalier Universitaire Vaudois CHUV
Rue du Bugnon 46
0 Lausanne
Kantonsspital Olten
Baslerstrasse 150
0 4600 Olten
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Kantonsspital Winterthur
Brauerstrasse 15
0 8401 Winterthur
Regionalspital Thun
Krankenhausstrasse 12
0 3600 Thun
Hopital de Sion
Avenue du Grand-Champsec 80
0 1951 Sion
Berlin Universitätsklinik Charité
Charitéplatz 1
0 10117 Berlin
Berlin Vivantes - Urban
Dieffenbachstraße 1
0 10967 Berlin
Berlin Vivantes - Neukölln
Rudower Strasse 48
0 Berlin 12351
Klinik Essen-Mitte
Henricistraße 92
0 Essen 45136
Universitätsklinikum Hamburg-Eppendorf
Martinistraße 52
0 Hamburg 20246
Uniklinik Köln
Kerpener Str. 62
0 Köln 50937
Klinikum Harlaching
Sanatoriumspl. 2
0 München 81545
Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
0 Tübingen 72076
Universitätsklinikum Ulm
Albert-Einstein-Allee 23
0 Ulm 89081
Alexianer Krefeld GmbH
Dießemer Bruch 81
0 47805 Krefeld
Universitätsklinikum RWTH Aachen
Pauwelsstraße 30
0 52074 Aachen
Universitaetsklinikum Düsseldorf
Moorenstraße 5
0 Düsseldorf 40225