A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer

NCT02136355

Non Small Cell Lung Cancer

COMPLETED NA

Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy

NCT02788461

Non-Small Cell Lung Cancer

ACTIVE_NOT_RECRUITING NA

Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

NCT00346320

Lung Cancer

COMPLETED NA

Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer

NCT00003685

Fatigue Lung Cancer Nausea and Vomiting +3 more

COMPLETED PHASE3

A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus

NCT02752126

Non-Small Cell Lung Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EBR plus HDRIB

External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)

Group Type EXPERIMENTAL

EBR plus HDRIB

Intervention Type RADIATION

EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks

EBR

External Beam Radiation (EBR)

Group Type ACTIVE_COMPARATOR

EBR

Intervention Type RADIATION

EBR of 20 Gy in 5 daily fractions over one week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EBR plus HDRIB

EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks

Intervention Type RADIATION

EBR

EBR of 20 Gy in 5 daily fractions over one week

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
* Stages III, IV or recurrent disease
* Documented endobronchial luminal disease by either endoscopy or CT-imaging
* Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis

Exclusion Criteria

* Age less than 18 years of age
* Uncontrolled or symptomatic brain metastases
* Anticipated survival of less than 3 months
* Systemic therapy planned to begin within 6 weeks following randomization
* Systemic therapy within 4 weeks of planned study randomization
* Any prior radiotherapy involving the lungs
* Cardiac arrest or myocardial infarction within 6 months prior to study randomization
* Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB
* Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women
* Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial
* Having received an investigational agent within one month of study randomization
* Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No