Non-small-cell Lung CancerNCT01745484
Role of SPECT in Radiotherapy of Lung Cancer and Toxicity Evaluation
A study testing SPECT-based treatment plan in people with Non-small-cell Lung Cancer and Radiation Pneumonitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
Overall objective of the study is to compare the use of SPECT in radiotherapy treatment planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer, Radiation Pneumonitis
- What is being tested?
- SPECT-based treatment plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Jul 2015
- 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
- Stage I-III non-small cell lung cancer, histologically verified
- Referred for definitive radiotherapy to the Department of Oncology, Aarhus University Hospital
- Meet the criteria for curatively intended radiotherapy described in details in the national guidelines
- Concurrent chemotherapy is accepted
- Adults over 18, that have given oral and written informed consent before patient registration
- The patients can only be randomized in this trial once
Who cannot join
- other uncontrolled malignancies
- human albumin allergy
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Aarhus University Hospital
Aarhus, DK-8000
About this study
Official title: Role of SPECT in Radiotherapy Treatment Planning and Toxicity Evaluation for the Patients With Stage I-III NSCLC
Overall objective of the study is to compare the use of SPECT in radiotherapy treatment planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer patients
Read the detailed description
Primary objective:
-To compare the rate of grade 2 or higher pneumonitis amongst patients with stage III NSCLC treated with radiotherapy using SPECT in radiotherapy treatment planning versus standard CT-based radiotherapy planning;
Secondary Objectives:
- To evaluate SPECT as a tool to predict lung toxicity;
- To establish estimates for the incidence and severity of pulmonary tissue effects observed in stage III NSCLC patients treated with radiotherapy;
- To generate hypotheses for subsequent use of SPECT-CT-based treatment planning as a method for minimization of toxicity risks
- To generate hypotheses for modeling studies of SPECT-CT-based treatment planning for dose-escalation;
- To compare the loco-regional control, time to progression and overall survival of patients treated with SPECT-based plan versus standard CT-based plan
- To compare the quality of life in patients randomized to the two study arms.
This trial is a single centre observational study. All patients will irrespective of their registration in the trial receive radiotherapy according to the standard treatment regimen at the Department of Oncology, Aarhus University Hospital. Participation implies baseline and follow-up procedures. In the treatment planning phase patients will be randomized to one of the following arms: Arm 1 SPECT/CT-based treatment plan with functional dose-volume parameters and Arrm 2 Standard CT-based plan with conventional dose-volume parameters.
The trial will consist of two parts. To initiate the trial a pilot study (part 1) will be performed to determine the feasibility in our setting at Aarhus University Hospital as it is described in the literature. Consecutive patients will be enrolled in the pilot study during 1-year period. The interim analysis after one year of enrollment will be performed to determine what patients are most likely to benefit from functional radiotherapy planning based on SPECT. The main objective of this part is to determine whether V/Q-SPECT data are valid and usable in the radiotherapy planning. The timing for acute and late follow-up SPECT will be determined. Randomized trial (part 2) will be performed thereafter.
Statistical analysis. The randomization by permitted blocks method will be used to allocate patients to treatment arm. Stratification factors will be age, gender, disease stage, histology, concurrent chemotherapy and irradiated volumes.
The chi-squire test (α=0.10) with the continuity correction will be used for analysis of the primary analysis. For all other comparisons, two-sided analyses will be performed and a p-value of 0.05 or less will be considered statistically significant. 95% confidence intervals will be constructed for outcomes of interest. Descriptive statistics will be used to summarize patient characteristics and outcomes by intervention arm. Differences in outcomes between intervention arms will be compared by using paired t-tests, Wilcoxon rank sum tests or McNemar tests as appropriate. Adjusting for stratification factors will be performed using logistic regression or linear regression. Time-to-event analyses will be estimated using the Kaplan-Meier method, and compared using Cox proportional hazards regression.
Estimation of the relationship between dose-volume parameters and toxicity will be evaluated using logistic regression analyses. Within patients who were planned using SPECT, the association between dose-volume parameters calculated using SPECT and those calculated under a CT-plan will be evaluated using correlation coefficients.
All patients who are randomized will be included in the analysis of safety and efficacy outcomes. Secondary analyses may be performed on those patients only on those who received radiotherapy as per the treatment plan based on SPECT or CT as per the intervention arm. Any patient who is randomized but does not receive radiotherapy based on the intervention allocated treatment plan will be described in detail along with the reason for not receiving the prescribed plan.
- Conditions
- Non-small-cell Lung Cancer, Radiation Pneumonitis
- Being tested
- SPECT-based treatment plan
- Keywords
- SPECT, Toxicity, Non-small-cell lung cancer, Definitive Radiotherapy, Radiation pneumonitis, Randomized study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-based treatment planOther
Also called Single Photon Emission Computed Tomography
SPECT will be performed on all patients at baseline. Two treatment plans will be made- functional SPECT-based plan and conventional CT-based plan. Randomization will take place if both plans are satisfying established criteria for tumour coverage and normal tissue sparing. Randomization between Arm 1 and Arm 2 will be done, where the patients will be treated either by SPECT-plan or by CT-plan respectively.
The SPECT data are viewed as a multicoloured image in the spectrum colour setting to allow accurate volume contouring around a predefined colour. The threshold level is adjusted individually for each patient in order to match the size of the SPECT image within the lung volumes defined on CT. A new contour of functional lung is created from the SPECT images using a threshold of 30% of the maximum uptake for each patient. A treatment plan is generated. The principal objective for each plan is to minimize the volume of lungirradiated
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | SPECT scan will be performed at baseline. Patients will receive radiotherapy according to standard CT-based plan with conventional dose-volume histogram Receives: Other: SPECT-based treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 radiation pneumonitis
The primary endpoint is grade 2 pneumonitis, defined according to the NCI Common Toxicity Criteria for Adverse Events (CTC) version 4.0.
Estimation of the occurrence of pulmonary tissue effects:
Number of patients developing pulmonary toxicity over grade 2 in both treatment arms according to the Common Terminology Criteria for Adverse Events CTC v. 4.0 and measured serially from 0 to 12 months after radiotherapy, as well as according to the SOMA-LENT scale measured serially from 0 to 12 months after radiotherapy
Measured: measured 0-12 months after completed radiotherapy
Secondary outcomes (3)
Overall quality of life score
Change in quality of life according to the standard quality of life questionnaires
Measured: 0-12 months after radiotherapy
Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more)
Estimation of conventional (from CT alone) and functional (from SPECT)dose-volume parameters (MLD and V5-50) and their correlation with pulmonary toxicity will be done.
Measured: 12 months after radiotherapy
Progression-free survival
Proportion of patients alive with no evidence of disease as per the RECIST criteria in the SPECT arm compared to CT arm
Measured: at 12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherina Farr, University of Aarhus
- Investigators
- Katherina Farr, MD, Principal investigator, Department of Oncology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745484
- Sponsor's protocol ID
- KFE-1203
- Status last verified
- Apr 2019
- First submitted
- 6 Dec 2012
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of SPECT in Radiotherapy Treatment Planning and Toxicity Evaluation for the Patients With Stage I-III NSCLC
- ClinicalTrials.gov ID
- NCT01745484
- Acronym / sponsor ID
- KFE-1203
- Conditions
- Non-small-cell Lung Cancer, Radiation Pneumonitis
- Keywords
- SPECT, Toxicity, Non-small-cell lung cancer, Definitive Radiotherapy, Radiation pneumonitis, Randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Dec 2012 (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.
Overall objective of the study is to compare the use of SPECT in radiotherapy treatment planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer patients
Detailed description
Primary objective:
-To compare the rate of grade 2 or higher pneumonitis amongst patients with stage III NSCLC treated with radiotherapy using SPECT in radiotherapy treatment planning versus standard CT-based radiotherapy planning;
Secondary Objectives:
- To evaluate SPECT as a tool to predict lung toxicity;
- To establish estimates for the incidence and severity of pulmonary tissue effects observed in stage III NSCLC patients treated with radiotherapy;
- To generate hypotheses for subsequent use of SPECT-CT-based treatment planning as a method for minimization of toxicity risks
- To generate hypotheses for modeling studies of SPECT-CT-based treatment planning for dose-escalation;
- To compare the loco-regional control, time to progression and overall survival of patients treated with SPECT-based plan versus standard CT-based plan
- To compare the quality of life in patients randomized to the two study arms.
This trial is a single centre observational study. All patients will irrespective of their registration in the trial receive radiotherapy according to the standard treatment regimen at the Department of Oncology, Aarhus University Hospital. Participation implies baseline and follow-up procedures. In the treatment planning phase patients will be randomized to one of the following arms: Arm 1 SPECT/CT-based treatment plan with functional dose-volume parameters and Arrm 2 Standard CT-based plan with conventional dose-volume parameters.
The trial will consist of two parts. To initiate the trial a pilot study (part 1) will be performed to determine the feasibility in our setting at Aarhus University Hospital as it is described in the literature. Consecutive patients will be enrolled in the pilot study during 1-year period. The interim analysis after one year of enrollment will be performed to determine what patients are most likely to benefit from functional radiotherapy planning based on SPECT. The main objective of this part is to determine whether V/Q-SPECT data are valid and usable in the radiotherapy planning. The timing for acute and late follow-up SPECT will be determined. Randomized trial (part 2) will be performed thereafter.
Statistical analysis. The randomization by permitted blocks method will be used to allocate patients to treatment arm. Stratification factors will be age, gender, disease stage, histology, concurrent chemotherapy and irradiated volumes.
The chi-squire test (α=0.10) with the continuity correction will be used for analysis of the primary analysis. For all other comparisons, two-sided analyses will be performed and a p-value of 0.05 or less will be considered statistically significant. 95% confidence intervals will be constructed for outcomes of interest. Descriptive statistics will be used to summarize patient characteristics and outcomes by intervention arm. Differences in outcomes between intervention arms will be compared by using paired t-tests, Wilcoxon rank sum tests or McNemar tests as appropriate. Adjusting for stratification factors will be performed using logistic regression or linear regression. Time-to-event analyses will be estimated using the Kaplan-Meier method, and compared using Cox proportional hazards regression.
Estimation of the relationship between dose-volume parameters and toxicity will be evaluated using logistic regression analyses. Within patients who were planned using SPECT, the association between dose-volume parameters calculated using SPECT and those calculated under a CT-plan will be evaluated using correlation coefficients.
All patients who are randomized will be included in the analysis of safety and efficacy outcomes. Secondary analyses may be performed on those patients only on those who received radiotherapy as per the treatment plan based on SPECT or CT as per the intervention arm. Any patient who is randomized but does not receive radiotherapy based on the intervention allocated treatment plan will be described in detail along with the reason for not receiving the prescribed plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: SPECT-based treatment planSPECT scan will be performed at baseline. Patients will receive radiotherapy according to standard CT-based plan with conventional dose-volume histogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage I-III non-small cell lung cancer, histologically verified
- Referred for definitive radiotherapy to the Department of Oncology, Aarhus University Hospital
- Meet the criteria for curatively intended radiotherapy described in details in the national guidelines
- Concurrent chemotherapy is accepted
- Adults over 18, that have given oral and written informed consent before patient registration
Key exclusion criteria (3 listed)
- other uncontrolled malignancies
- human albumin allergy
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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 |
|---|---|---|
| SPECT-based treatment planAlso: Single Photon Emission Computed TomographySPECT will be performed on all patients at baseline. Two treatment plans will be made- functional SPECT-based plan and conventional CT-based plan. Randomization will take place if both plans are satisfying established criteria for tumour coverage and normal tissue sparing. Randomization between Arm 1 and Arm 2 will be done, where the patients will be treated either by SPECT-plan or by CT-plan respectively. The SPECT data are viewed as a multicoloured image in the spectrum colour setting to allow accurate volume contouring around a predefined colour. The threshold level is adjusted individually for each patient in order to match the size of the SPECT image within the lung volumes defined on CT. A new contour of functional lung is created from the SPECT images using a threshold of 30% of the maximum uptake for each patient. A treatment plan is generated. The principal objective for each plan is to minimize the volume of lungirradiated | Other | Arm 1 |
Primary outcome
Grade 2 radiation pneumonitis
Time frame: measured 0-12 months after completed radiotherapy
The primary endpoint is grade 2 pneumonitis, defined according to the NCI Common Toxicity Criteria for Adverse Events (CTC) version 4.0. Estimation of the occurrence of pulmonary tissue effects: Number of patients developing pulmonary toxicity over grade 2 in both treatment arms according to the Common Terminology Criteria for Adverse Events CTC v. 4.0 and measured serially from 0 to 12 months after radiotherapy, as well as according to the SOMA-LENT scale measured serially from 0 to 12 months after radiotherapy
3 secondary outcomes
Overall quality of life score
Time frame: 0-12 months after radiotherapy
Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more)
Time frame: 12 months after radiotherapy
Progression-free survival
Time frame: at 12 months after radiotherapy
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 25 Apr 2019.
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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.
Katherina Farr, MD principal investigator
Department of Oncology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT-based treatment plan in people with Non-small-cell Lung Cancer and Radiation Pneumonitis, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 3 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 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Grade 2 radiation pneumonitis (time frame: measured 0-12 months after completed radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2019.