Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Other: questionnaire administration Procedure: quality-of-life assessment Radiation: 3-dimensional conformal radiation therapy Radiation: palliative radiation therapy Radiation: whole-brain radiation therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer |
- Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]
- Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13) [ Time Frame: 2015 ] [ Designated as safety issue: No ]
- Local intra-thoracic symptoms [ Time Frame: 2015 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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: palliative radiation therapy Radiation: whole-brain 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Ireland | |
| St Luke's Radiation Oncology Network (SLRON) | Recruiting |
| Dublin, Ireland, 6 | |
| Contact: Contact Person 01 4065000 | |
| Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Contact Person 00 353 (0)91 524222 | |
| Principal Investigator: | John Gerard Armstrong, MD, MB, MRCPI | Saint Luke's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01176487 History of Changes |
| Other Study ID Numbers: | CDR0000682636, ICORG-06-34, EU-21056 |
| Study First Received: | August 5, 2010 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Ireland: Research Ethics Committee |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
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 |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013