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Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

questionnaire administration

quality-of-life assessment

3-dimensional conformal radiation therapy

palliative radiation therapy

whole-brain radiation therapy

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-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)

Sites / Locations

St Luke's Radiation Oncology Network (SLRON)
Galway University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Local intra-thoracic symptoms

Full Information

NCT ID

NCT01176487

First Posted

August 5, 2010

Last Updated

March 30, 2016

Sponsor

Cancer Trials Ireland

1. Study Identification

Unique Protocol Identification Number

NCT01176487

Brief Title

Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34

Official Title

A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Trials Ireland

4. Oversight

5. Study Description

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.

Detailed Description

The primary purpose of this study is to demonstrate that using technically sophisticated 3-dimensional conformal radiation therapy for the palliative treatment of lung cancer patients will result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis. Single arm therapeutic clinical study. RT Treatment Regimens: 17 Gy/2 fractions or 20Gy/5 fractions or 39Gy/13 fractions Primary Endpoint: -The occurrence of Grade 3 or higher oesophagitis in the interval between start and 1-month post completion of treatment as determined by CTCAE Version 4.02 Patients will be assessed pre treatment, during treatment, 2 weeks post completion of treatment, one month post completion of treatment, three months post completion of treatment, and three monthly thereafter -All patients who complete treatment (and whose on-treatment toxicity is documented) will be evaluable. Secondary Endpoint: Quality of Life Assessment. All patients will be required to complete the EORTC QLQ-C15-PAL (Version 1) and the Lung Specific Module (LC 13) The occurrence of other AEs Safety Endpoint: -Radio-induced oesophagitis, acute and long term, using the CTCAE Version 4.02.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

3-dimensional conformal radiation therapy

Intervention Type

Radiation

Intervention Name(s)

palliative radiation therapy

Intervention Type

Radiation

Intervention Name(s)

whole-brain radiation therapy

Primary Outcome Measure Information:

Title

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

Time Frame

2015

Title

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

Time Frame

2015

Secondary Outcome Measure Information:

Title

Local intra-thoracic symptoms

Time Frame

2015

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: -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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Gerard Armstrong, MD, MB, MRCPI

Organizational Affiliation

Saint Luke's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Luke's Radiation Oncology Network (SLRON)

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Galway University Hospital

City

Galway

Country

Ireland

12. IPD Sharing Statement

Citations:

PubMed Identifier

29548561

Citation

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.

Results Reference

derived

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Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34

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