Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer - Full Text View

Sponsor:	All Ireland Cooperative Oncology Research Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01176487

Purpose

RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by palliative radiation therapy and improve the quality of life of patients with lung cancer.

PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy works in reducing the side effects of palliative radiation in patients with lung cancer.

Condition	Intervention
Lung Cancer	Other: questionnaire administration Procedure: quality-of-life assessment Radiation: 3-dimensional conformal radiation therapy Radiation: palliative radiation therapy Radiation: whole-brain radiation therapy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Primary Purpose: Supportive Care
Official Title:	A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 [ Designated as safety issue: Yes ]
Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of other adverse events [ Designated as safety issue: Yes ]
Local intra-thoracic symptoms [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2010
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To determine if 3-dimensional conformal radiotherapy for palliative treatment will result in equivalent degrees of symptom relief and a reduction in esophagitis in patients with lung cancer.

OUTLINE: Patients undergo 3-dimensional conformal radiotherapy once a week for 2 weeks (2 fractions) OR once a day for 1 week (5 fractions) OR once a day for 3 weeks (13 fractions). Patients may also undergo whole-brain radiotherapy at the discretion of the treating physician.

Patients complete a quality-of-life questionnaire (EORTC QLQ-C15-Pal Version 1) and the Lung Specific Module (LC 13) at baseline and at 1 month.

After completion of study treatment, patients are followed up at 2 weeks, at 1 month, and then every 3 months thereafter.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of small cell or non-small cell lung cancer
- Locally advanced or metastatic disease
Presence of intra-thoracic symptoms requiring palliative treatment
- Intra-thoracic disease requiring palliation must be clearly evident on a diagnostic CT scan without the presence of a pleural effusion
No pleural effusions

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-3 OR Karnofsky PS 40-100%
Life expectancy ≥ 3 months
- Must have a reasonable life expectancy with a reasonable prospect of having quality-of-life measurements taken at the study endpoint time lines
Patient's condition must permit waiting for the 3-dimensional design process to be implemented, at the discretion of the consultant physician
No evidence of severe uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease), in the opinion of the investigator
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Concurrent whole-brain irradiation (if required) is permitted

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176487

Locations

Ireland
Saint Luke's Hospital	Recruiting
Dublin, Ireland, 6
Contact: Contact Person 353-1-406-5000 Armstrongtravelling@gmail.com
Galway University Hospital	Recruiting
Galway, Ireland
Contact: Contact Person 353-1-893-487 Cormac.Small@hse.ie

Sponsors and Collaborators

All Ireland Cooperative Oncology Research Group

Investigators

Principal Investigator:

John Gerard Armstrong, MD, MB, MRCPI

Saint Luke's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT01176487 History of Changes
Other Study ID Numbers:	CDR0000682636, ICORG-06-34, EU-21056
Study First Received:	August 5, 2010
Last Updated:	December 6, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
recurrent small cell lung cancer
extensive stage small cell lung cancer

stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012