Trial document





This trial has been registered retrospectively.
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  DRKS00005026

Trial Description

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Title

Carboplatin chemotherapy and involved node radiotherapy in stage IIA/B seminoma.

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Trial Acronym

SAKK01/10

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URL of the Trial

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Brief Summary in Lay Language

The testicular seminoma is the most common malignant tumor of young men, the stage IIa/b is characterized by up to 5 cm in diameter in the lymph nodes below the diaphragm. The standard treatment in this stage is a large-volume radiation of lymph node regions below the diaphragm or more cycles of intensive chemotherapy each with 3 drugs. Both standard treatments are highly effective, in more than 90% of all patients, the tumor is thus permanently cured. However, both standard treatments also carry risks for these usually young and healthy patients. Radiation therapy is associated with fatigue, nausea, and diarrhea. Chemotherapy can cause fatigue, nausea, hair loss and susceptibility to infection. As a late consequence, this could lead to kidney dysfunction and intestinal strictures or adhesions after large-volume irradiation. The risk for the development of tumors in the irradiated area is increased. The intensive chemotherapy can cause permanent damage of the kidneys, lungs and organs of hearing. Other tumors are more common, especially blood cancer. The prognosis for patients with seminoma stage IIA / B are very high with modern standard treatments and therefore unlikely to improve. Therefore, the focus of future research should be the prevention and reduction of side effects of the therapy. A combination treatment of radiation and chemotherapy, respectively in attenuated form, is as effective as one of the standard treatments and is associated with fewer side effects. The aim of the study is the testing of efficacy as well as the short-and long-term tolerability of the new combination treatment of radiation and chemotherapy.

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Brief Summary in Scientific Language

Testicular cancers are the most common malignancies in men aged between 18-35 years. Seminoma is classified according to the involvement of and degree of spreading to lymph nodes and to the lung or other organs. Around 10% of all seminoma patients are diagnosed with stage IIA/B disease. Stage IIA patients have one or more enlarged regional lymph nodes, 2 cm or less in greatest dimension, without evidence of distant disease (cN1 cM0). Stage IIB patients have one or more enlarged regional lymph nodes more than 2 cm but not more than 5 cm in greatest dimension, without evidence of distant disease (cN2 cM0). Paraaortic, interaortocaval, para-/pre-/retrocaval and pre-/retroaortic lymph nodes are considered regional. Intrapelvic, external iliac and inguinal lymph nodes are considered regional only after scrotal or inguinal surgery.
Seminoma stage IIA/B is highly responsive to chemotherapy or radiation therapy and the progression free survival at 5 or 6 years with such treatments is between 87-95%. Supra-diaphragmatic lymph nodes are the usual site of tumor recurrence after radiation therapy, while local failure or tumor persistence in paraaortic lymph nodes is predominant after chemotherapy.
Current standard of therapy in patients with stage IIA/B seminoma involves either large volume paraaortic and ipsilateral pelvic radiation therapy (“dogleg field”) or three cycles of chemotherapy with BEP (Bleomycin, Etoposide, Cisplatin). While both treatment modalities offer high rates of progression free survival and overall survival, they also potentially bear the risk of unwanted events during and following the treatment. Large volume radiation therapy is associated with fatigue, nausea and vomiting during treatment.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005026
  •   2013/10/14
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  •   yes
  •   Approved
  •   292/2013AMG1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   2011-005840-87 
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Health Condition or Problem studied

  •   Seminoma stage IIa/b
  •   C62.9 -  Malignant neoplasm: Testis, unspecified
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Interventions/Observational Groups

  •   Day 1: 1 dose (21 days) Carboplatin 10mg/ml Accord AUC7
    from Day 22: radiotherapy 30Gy (stage IIa) or 36 Gy (stage IIb).
    The total duration of treatment is 6 weeks for patients with stage IIA and 6.5 weeks for patients with stage IIB. In the first 3 weeks of the treatment there is a one-time outpatient infusion of chemotherapy for about 1 hour as well as the for radiotherapy required treatment planning. Three weeks after administration of single chemotherapy, radiation therapy, which lasts 3 or 3.5 weeks, starts. Radiation therapy is performed by a daily outpatient radiation (Monday to Friday).
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   No
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Primary Outcome

Progression free survival (PFS) at 3 years

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Secondary Outcome

- Adverse events (AEs) temporarily associated
with the trial treatment (within 30 days after treatment)

- Late AEs (within 20 years after treatment)

- Incidence of secondary malignancies

- Response rate

- Time to progression (TTP)

- Overall survival (OS) (in between 20 years)

- Seminoma specific survival (in between 20 years)

- PFS (in between 3 years)

- Localization of progression

- Development of metabolic syndrome

- Development of hypogonadism

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/18
  •   120
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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 (see Appendix 2) [15].
- 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 (see Appendix 3). Oral and i.v. contrast have to be administered.
- Age ≥ 18 years.
- WHO performance status 0-2 (see Appendix 5).
- 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, see Appendix 4).
- Patient agrees not to father a child during trial treatment and during 12 months thereafter.
- Patient has been proposed sperm conservation.
- Patient compliance

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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.
- 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).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • SAKK Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung
    • Ms.  Dr.  Corinne  Schär 
    • Effingerstr. 33
    • CH-3008  Bern
    • Switzerland
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    • Universitätsklinikum Tübingen Klinik für Urologie
    • Mr.  Professor Dr.  Jens  Bedke 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen Klinik für Urologie
    • Mr.  Professor Dr.  Jens  Bedke 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • SAKK Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung
    • Effingerstr. 40
    • CH-3008  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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