Lung CancerNCT01176487
Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34
A study testing questionnaire administration, quality-of-life assessment and 3-dimensional conformal radiation therapy in people with Lung Cancer, run by Cancer Trials Ireland at 2 sites in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and 3-dimensional conformal radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIreland
- Study dates
- Jun 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- -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)
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
St Luke's Radiation Oncology Network (SLRON)
Dublin, 6
Galway University Hospital
Galway
About this study
Official title: 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.
Read the 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
- Being tested
- questionnaire administration, quality-of-life assessment, 3-dimensional conformal radiation therapy, palliative radiation therapy, whole-brain radiation therapy
- Keywords
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
3-dimensional conformal radiation therapyRadiation
palliative radiation therapyRadiation
whole-brain radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy; Radiation: palliative radiation therapy; Radiation: whole-brain radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02
Measured: 2015
Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13)
Measured: 2015
Secondary outcomes (1)
Local intra-thoracic symptoms
Measured: 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- John Gerard Armstrong, MD, MB, MRCPI, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176487
- Sponsor's protocol ID
- 06-34 ICORG
- Other IDs
- ICORG-06-34, EU-21056
- Status last verified
- Mar 2016
- First submitted
- 5 Aug 2010
- Last updated
- 31 Mar 2016
- Results posted
- No
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.
PubMed 29548561
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer
- ClinicalTrials.gov ID
- NCT01176487
- Acronym / sponsor ID
- 06-34 ICORG
- Conditions
- Lung Cancer
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: questionnaire administration, Procedure: quality-of-life assessment, Radiation: 3-dimensional conformal radiation therapy, Radiation: palliative radiation therapy, Radiation: whole-brain radiation therapyA clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | A |
| quality-of-life assessment | Procedure or surgery | A |
| 3-dimensional conformal radiation therapy | Radiation | A |
| palliative radiation therapy | Radiation | A |
| whole-brain radiation therapy | Radiation | A |
Primary outcome
Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02
Time frame: 2015
Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13)
Time frame: 2015
1 secondary outcome
Local intra-thoracic symptoms
Time frame: 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 29548561McDermott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gerard Armstrong, MD, MB, MRCPI principal investigator
Saint Luke's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, quality-of-life assessment and 3-dimensional conformal radiation therapy in people with Lung Cancer, run by Cancer Trials Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 (time frame: 2015). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01176487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.