NCT01176487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

3.5 years

First QC Date

August 5, 2010

Last Update Submit

March 30, 2016

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerrecurrent small cell lung cancerextensive stage small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02

    2015

  • Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13)

    2015

Secondary Outcomes (1)

  • Local intra-thoracic symptoms

    2015

Study Arms (1)

A

EXPERIMENTAL

A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer

Other: questionnaire administrationProcedure: quality-of-life assessmentRadiation: 3-dimensional conformal radiation therapyRadiation: palliative radiation therapyRadiation: whole-brain radiation therapy

Interventions

questionnaire administrationOTHER
A
quality-of-life assessmentPROCEDURE
A
3-dimensional conformal radiation therapyRADIATION
A
palliative radiation therapyRADIATION
A
whole-brain radiation therapyRADIATION
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Karnofsky Performance Status of \> or equal to 40%
  • Patients with locally advanced or metastatic small cell or non-small cell lung cancer
  • The presence of intra-thoracic symptoms requiring palliative treatment
  • WBI (if required) is permitted
  • The patient's condition must permit waiting for the 3-dimensional design process to be implemented. This will be at the discretion of the Consultant Physician
  • Patients presenting with pleural effusions - provided the pleural effusion does not prevent the reasonably accurate delineation of the target volume
  • Intra-thoracic disease requiring palliation must be clearly evident on a diagnostic CT scan
  • Life expectancy of at least 3 months (assessed by clinician)
  • Provision of written informed consent in line with ICH-GCP guidelines

You may not qualify if:

  • In the opinion of the Investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Luke's Radiation Oncology Network (SLRON)

Dublin, 6, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Related Publications (1)

  • McDermott RL, Armstrong JG, Thirion P, Dunne M, Finn M, Small C, Byrne M, O'Shea C, O'Sullivan L, Shannon A, Kelly E, Hacking DJ. Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer. Radiother Oncol. 2018 May;127(2):253-258. doi: 10.1016/j.radonc.2018.02.028. Epub 2018 Mar 13.

    PMID: 29548561DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • John Gerard Armstrong, MD, MB, MRCPI

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 6, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2013

Study Completion

March 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

IE(2)