Know Cancer

forgot password

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

18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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

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

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.

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

John Gerard Armstrong, MD, MB, MRCPI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital


Ireland: Research Ethics Committee

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms