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

• ClinicalTrials.gov Identifier: NCT02354274
• Recruitment Status: Recruiting
• First Posted: February 3, 2015
• Last Update Posted: April 25, 2022
• Sponsor: Olfred Hansen
• Collaborators: Odense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Vejle Hospital; Naestved Hospital; Aalborg University Hospital; Herlev Hospital
• Information provided by (Responsible Party): Olfred Hansen, Odense University Hospital

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
NSCLC	Radiation: Escalated: Inhomogeneous dose plan; Radiation: Standard: Homogeneous dose plan	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Two independent radiation plans are made before randomization to ensure best available plans for both arms and trial.
• Primary Purpose: Treatment
• Official Title: Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
• Actual Study Start Date: January 2015
• Estimated Primary Completion Date: October 2029
• Estimated Study Completion Date: October 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Olfred Hansen, MD; +4565411867; olfred.hansen@rsyd.dk

Locations

Denmark

Aalborg University Hospital; Not yet recruiting

Aalborg, Denmark, 9100

Contact: Svetlana Kunwald, MD

Principal Investigator: Svetlana Kunwald, MD

Aarhus University Hospital; Recruiting

Aarhus, Denmark, 8000

Contact: Marianne M. Knap, MD

Principal Investigator: Marianne M. Knap, MD

Rigshospitalet; Not yet recruiting

Copenhagen, Denmark, 2100

Contact: Gitte F. Persson, MD

Herlev University Hospital; Recruiting

Herlev, Denmark, 2730

Contact: Jon L. Andersen, MD

Principal Investigator: Jon L. Andersen, MD

Department of Oncology, Naestved Hospital; Not yet recruiting

Naestved, Denmark

Contact: Kim Wederwang, MD kwd@regionsjaelland.dk

Principal Investigator: Kim Wedervang, MD

Department of Oncology, Odense University Hospital; Recruiting

Odense, Denmark, 5000

Contact: Olfred Hansen, MD +45 6541 1867 olfred.hansen@rsyd.dk

Principal Investigator: Olfred Hansen, MD

Sub-Investigator: Tine Schytte, MD

Department of Oncology, Vejle Hospital; Recruiting

Vejle, Denmark, 7100

Contact: Christa Haugaard, MD

Principal Investigator: Christa Haugaard, MD

Sponsors and Collaborators

Olfred Hansen

Odense University Hospital

Aarhus University Hospital

Rigshospitalet, Denmark

Vejle Hospital

Naestved Hospital

Aalborg University Hospital

Herlev Hospital

More Information

• Responsible Party: Olfred Hansen, MD, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02354274
• Other Study ID Numbers: NARLAL 2
• First Posted: February 3, 2015
• Last Update Posted: April 25, 2022
• Last Verified: April 2022