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

Olfred Hansen330 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

NSCLC

Interventions

Escalated: Inhomogeneous dose planRADIATION

Standard: Homogeneous dose planRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Aalborg University Hospital

Aalborg, Denmark

NOT_YET_RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 5-7 years

Secondary Outcomes

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

Time frame: 10 years

Survival

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

Time frame: 15 years

Progression free survival

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

Time frame: 15 years

Central Contacts

Olfred Hansen, MD

CONTACT

+4565411867 olfred.hansen@rsyd.dk

Data from ClinicalTrials.gov

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