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®

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

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Radiation: Standard: Homogeneous dose plan; Radiation: Escalated: Inhomogeneous dose plan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olfred Hansen, MD; Phone Number: +4565411867; Email: olfred.hansen@rsyd.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Not yet recruiting
    • Aalborg University Hospital
    • Contact: Svetlana Kunwald, MD
    • Principal Investigator: Svetlana Kunwald, MD
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital
    • Contact: Marianne M. Knap, MD
    • Principal Investigator: Marianne M. Knap, MD
  • Copenhagen, Denmark, 2100
    • Not yet recruiting
    • Rigshospitalet
    • Contact: Gitte F. Persson, MD
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev University Hospital
    • Contact: Jon L. Andersen, MD
    • Principal Investigator: Jon L. Andersen, MD
  • Naestved, Denmark
    • Not yet recruiting
    • Department of Oncology, Naestved Hospital
    • Principal Investigator: Kim Wedervang, MD
    • Contact: Kim Wederwang, MD; Email: kwd@regionsjaelland.dk
  • Odense, Denmark, 5000
    • Recruiting
    • Department of Oncology, Odense University Hospital
    • Contact: Olfred Hansen, MD; Phone Number: +45 6541 1867; Email: olfred.hansen@rsyd.dk
    • Principal Investigator: Olfred Hansen, MD
    • Sub-Investigator: Tine Schytte, MD
  • Vejle, Denmark, 7100
    • Recruiting
    • Department of Oncology, Vejle Hospital
    • Contact: Christa Haugaard, MD
    • Principal Investigator: Christa Haugaard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard: Homogeneous dose plan; Treatment will be given over 33 treatments. The dose is 66 Gy.	Radiation: Standard: Homogeneous dose plan
Experimental: Escalation: Inhomogeneous dose plan; Radiation dose is increased to tumor and lymph nodes based on an inhomogeneous dose distribution determined by the most active ( FDG-PET criteria ) area of the node compared to a standard uniform dose distribution. Treatment will be given over 33 treatments. The dose is as high as possible taking the tolerance of the normal tissue into consideration	Radiation: Escalated: Inhomogeneous dose plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)	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.	5-7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity (graded after CTCAE 4.0 assessed by physician)	Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits	10 years
Survival	Time from randomization to exact date of death of any cause.	15 years
Progression free survival	Time from randomization to date of progression, death, or occurence of metastatic disease	15 years

Collaborators and Investigators

• Sponsor: Olfred Hansen
• Collaborators: Odense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Herlev Hospital; Vejle Hospital; Aalborg University Hospital; Naestved Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): October 1, 2029
• Study Completion (Anticipated): October 1, 2029

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NARLAL 2