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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02354274
• Other study ID #: NARLAL 2
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 2029

Study information

• Verified date: April 2022
• Source: Odense University Hospital
• Contact: Olfred Hansen, MD
• Phone: +4565411867
• Email: olfred.hansen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: October 2029
• Est. primary completion date: October 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

Radiation:
• Escalated: Inhomogeneous dose plan

• Standard: Homogeneous dose plan

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev University Hospital	Herlev
Denmark	Department of Oncology, Naestved Hospital	Naestved
Denmark	Department of Oncology, Odense University Hospital	Odense
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (8)

Lead Sponsor	Collaborator
Olfred Hansen	Aalborg University Hospital, Aarhus University Hospital, Herlev Hospital, Naestved Hospital, Odense University Hospital, Rigshospitalet, Denmark, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Survival	Time from randomization to exact date of death of any cause.	15 years
Secondary	Progression free survival	Time from randomization to date of progression, death, or occurence of metastatic disease	15 years