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

NCT ID: NCT01176487

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2016-03-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

palliative radiation therapy

Intervention Type: RADIATION

whole-brain radiation therapy

Intervention Type: RADIATION

Interventions

questionnaire administration

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

palliative radiation therapy

Intervention Type: RADIATION

whole-brain radiation therapy

Intervention Type: RADIATION

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Gerard Armstrong, MD, MB, MRCPI

Role: PRINCIPAL_INVESTIGATOR

Saint Luke's Hospital

Locations

St Luke's Radiation Oncology Network (SLRON)

Dublin, , Ireland

Galway University Hospital

Galway, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 29548561 (View on PubMed)

Other Identifiers

ICORG-06-34

Identifier Type: -

Identifier Source: secondary_id

EU-21056

Identifier Type: -

Identifier Source: secondary_id

06-34 ICORG

Identifier Type: -

Identifier Source: org_study_id