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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. Read our disclaimer for details. Identifier: NCT01593241
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : April 16, 2019
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

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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

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Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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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:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT01593241    
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 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Antineoplastic Agents