Trial document




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  DRKS00006323

Trial Description

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Title

Ion Therapy within the Trimodal Management of Superior Sulcus Tumors

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Trial Acronym

INKA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The standard treatment for sulcus superior tumors without distant metastases is a combination of chemoradiation followed by surgical resection. Carbon ion beam treatments offer several possible advantages over classical photon beam radiation, for example a higher biological efficacy. Within this study protocol the standard photon beam radiation is replaced by carbon ion beams. We plan to treat 20 patients with this combined approach, applying 13 carbon ion secessions in combination with chemotherapy followed by surgery. Primary endpoints are feasibility and safety.

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Brief Summary in Scientific Language

The standard treatment for sulcus superior tumors without distant metastases is a combination of chemoradiation followed by surgical resection. Carbon ion beam treatments offer several possible advantages over classical photon beam radiation, for example a higher biological efficacy. Within this study protocol the standard photon beam radiation is replaced by carbon ion beams. We plan to treat 20 patients with this combined approach, applying 13 carbon ion fractions in combination with chemotherapy followed by surgery. Primary endpoints are feasibility and safety.

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Organizational Data

  •   DRKS00006323
  •   2014/10/07
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  •   yes
  •   Approved
  •   S-025/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C34.1 -  Malignant neoplasm: Upper lobe, bronchus or lung
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Interventions/Observational Groups

  •   Preoperative particle therapy (39GyE in 13 fractions) of the primary tumor and adjective lymphatic drainage in combination with a cisplatin/vinorelbine chemotherapy followed by surgical resection
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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)
  •   N/A
  •   N/A
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Primary Outcome

Safety and feasibility based on the incidence of NCI-CTC-AE °3/4 side effects and/or discontinuance due to any reason

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Secondary Outcome

Regression rate, metabolic tumor regression, morphologic tumor regression, quality of life (EORTC QLQ-C30, LC13) after 5-7, 13-15 weeks and 6 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/10/06
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

• histological confirmed superior sulcus tumor (NSCLC)
• maximal stage N1 in a FDG-PET-CT (not older than 6 weeks)
• age between 18 and 75 years
• Karnofsky Performance Score >/=70
• Written informed consent (must be available before enrolment in the trial)

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Exclusion Criteria

• refusal of the patients to take part in the study
• medical contraindications against one of the parts in the trimodal concept
• stage N2/3 disease in FDG-PET-CT
• stage IV disease
• previous radiotherapy of the thoracic region
• Participation in another clinical study or observation period of competing trials, respectively
• no capacity to consent
• active medical devices, for which no approval for ion-therapy exists (i.e. cardiac pacemaker, defibrillator, …)
• decompensated diseases of the lungs, cardio-pulmonal system, metabolism, hematopoetic system, coagulation system or renal function

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Klaus  Herfarth 
    • INF 400
    • 69120  Heidelberg
    • Germany
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    • StudiensekretariatUniversitätsklinikum Heidelberg
    • Ms.  K.  Lossner 
    • INF 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • DFG
    • Kennedyallee 40
    • 53175   Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.