Trial document





This trial has been registered retrospectively.
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  DRKS00008887

Trial Description

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Title

Adjuvant radiation of patients with involvement of mediastinal lymph nodes (pN2) and complete resection of Non Small Cell Lung Cancer: a retrospective analysis of patients of the department of Radiation Oncology Freiburg

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study a retrospective analysis of patients with a Non-Small Cell Lung Cancer with a pN2 tumor stage and without distant metastases will be performed. Patients who received surgical treatment followed by radiotherapy of the tumor region and adjuvant or neo-adjuvant chemotherapy will be included in the investigation. The objective is to evaluate the benefit of the radiation treatment (e.g. were there any recurrences in the irradiated area or beyond, etc.) and additionally what negative
consequences they suffered (radiation pneumonitis, heart damage, etc.). This may improve the assessment whether adjuvant radiotherapy in the currently applied manner provides an advantage and is adequate in the respective situation.

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Brief Summary in Scientific Language

To date there is no clear answer to the question whether operated patients with NSCLC stage cM0, with R0 resection but histologically proven mediastinal lymph node involvement (pN2), benefit from the adjuvant radiotherapy of the primary tumor region and the involved and / or elective adjacent lymph node regions. The relevant literature presents contradictory conclusions on this issue. However, an advantage regarding improvement of locoregional control for the patients by means of adjuvant radiotherapy is assumed and is currently under investigation in ongoing clinical studies (e.g. in Freiburg since 2013: the Lung ART study, a Phase III study comparing post-operative conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 involvement, and since 2015 PORTAF, Postoperative Radiotherapy of Non-Small Cell Lung Cancer: Accelerated vs. Conventional Fractionation).

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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

  •   DRKS00008887
  •   2015/09/10
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  •   yes
  •   Approved
  •   77/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Patients with histologically confirmed involvement of mediastinal lymph nodes (pN2) of a NSCLS, who qualify for an optional adjuvant radiation of the primary tumor region and the involved lymph node region. Timeframe: 2008 - 2013. Using the (electronic) patient records, relevant data (tumor-specific data, resection status, neoadjuvant/adjuvant chemotherapy, radiation dose) are collected and used for survival (relapse-free and overall) and toxicity evaluation
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Overall survival (retrospective evaluation)

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Secondary Outcome

1) Loco-regional relapse-free survival: prognostic relevance of the radiation therapy, time interval until progress/relapse after end of radiation therapy or surgery
2) Survival without distant metastases
3) Therapy-associated toxicity. Acute and long-term implications of the radiation therapy (like radioodermatitis, dysphagia, hemotoxicity, radiopneumonitis/-fibrosis)
(retrospective evaluation)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/05/20
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- age >= 18 years,
- pN2 after surgery of the primary tumor and systematic mediastinal lymphadenectomy
- with histologically confirmed NSCLC

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Exclusion Criteria

- R1-status after surgery, because then radiation is indicated in any case
- distant metastases
- pN1 or pN3

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Ursula  Nestle 
    • Robert-Kochstr 3
    • 79106  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Ursula  Nestle 
    • Robert-Kochstr 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Ursula  Nestle 
    • Robert-Kochstr 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/15
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Trial Publications, Results and other Documents

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