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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176487
• Other study ID #: 06-34 ICORG
• Secondary ID: ICORG-06-34EU-21
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: March 30, 2016
• Start date: June 2010
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• quality-of-life assessment

Radiation:
• 3-dimensional conformal radiation therapy

• palliative radiation therapy

• whole-brain radiation therapy

Locations

Country	Name	City	State
Ireland	St Luke's Radiation Oncology Network (SLRON)	Dublin
Ireland	Galway University Hospital	Galway

Sponsors (1)

Lead Sponsor	Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02		2015	Yes
Primary	Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13)		2015	No
Secondary	Local intra-thoracic symptoms		2015	No