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

Not Applicable

Recruiting

• Conditions: NSCLC

• Registration Number: NCT02354274
• Lead Sponsor: Olfred Hansen

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)	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

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

Trial Locations

Locations (7)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Oncology, Naestved Hospital; 🇩🇰 Naestved, Denmark

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Oncology, Odense University Hospital; 🇩🇰 Odense, Denmark

Herlev University Hospital; 🇩🇰 Herlev, Denmark