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NCT Number: NCT02354274

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

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

Recruiting

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Escalated: Inhomogeneous dose plan

Radiation

Standard: Homogeneous dose plan

Radiation

Primary outcomes

  1. Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)

    Time frame: 5-7 years

    Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen ) every 3 months combined with PET/CT every 9 months or if occurrence is clinically suspected. Suspicion of tumor relapse local, regional or distant should be verified by biopsy. Date of detected recurrence is the date of the imaging modality suspecting relapse. The patient will be censured at death without local relapse.

Secondary outcomes

  1. Toxicity (graded after CTCAE 4.0 assessed by physician)

    Time frame: 10 years

    Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits

  2. Survival

    Time frame: 15 years

    Time from randomization to exact date of death of any cause.

  3. Progression free survival

    Time frame: 15 years

    Time from randomization to date of progression, death, or occurence of metastatic disease

Study contacts

Contact information is provided by the study sponsor or research team.

Olfred Hansen, MD

CONTACT

[email protected]

+4565411867

Sponsors and collaborators

Lead sponsor

Olfred Hansen

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Herlev Hospital
  • Naestved Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Vejle Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2029
Study completion
2029
First posted
Feb 3, 2015
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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