RecruitingNot ApplicableNCT02354274

Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®

Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®


Sponsor

Olfred Hansen

Enrollment

330 participants

Start Date

Jan 1, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB
  • Performance status 0-1
  • Able to comply with treatment and follow study and follow-up procedures
  • Women must have negative pregnancy test
  • Signed, informed consent
  • Plan for radiotherapy with conventional 66 Gy/ 33 F, which meets all dosing limits two normal tissue must be available

Exclusion Criteria7

  • Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease)
  • Need for nasal oxygen
  • Former thoracic radiotherapy, unless there is no significant overlap with previous fields
  • Any other active malignant disease
  • Unable to take oral medications or needing intravenous nutrition
  • Ulcer
  • Nursing women

Interventions

RADIATIONEscalated: Inhomogeneous dose plan
RADIATIONStandard: Homogeneous dose plan

Locations(7)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Herlev University Hospital

Herlev, Denmark

Department of Oncology, Naestved Hospital

Næstved, Denmark

Department of Oncology, Odense University Hospital

Odense, Denmark

Department of Oncology, Vejle Hospital

Vejle, Denmark

View Full Details on ClinicalTrials.gov

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NCT02354274


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