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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy; Radiation: whole-brain radiation therapy; Radiation: palliative radiation therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 6
    • St Luke's Radiation Oncology Network (SLRON)
  • Galway, Ireland
    • Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer	Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy; Radiation: whole-brain radiation therapy; Radiation: palliative radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Local intra-thoracic symptoms	2015

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI, Saint Luke's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; extensive stage small cell lung cancer; recurrent 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: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 06-34 ICORG; ICORG-06-34; EU-21056