Lung CancerPhase 2NCT00958321
Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35
A Phase 2 study testing computed tomography, 3-dimensional conformal radiation therapy and fludeoxyglucose F 18 in people with Lung Cancer and Metastatic Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
Trial summary
RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Metastatic Cancer
- What is being tested?
- computed tomography, 3-dimensional conformal radiation therapy and fludeoxyglucose F 18
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2007to Dec 2016
- Phase
- Phase 2
- 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
- Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
- TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
- Measurable disease
- No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
- Patient suitable for radical 3-DCRT
- ECOG-Performance status ≤ 2 / KPS > or equal to 60
Show all 12Show fewer
- Weight loss <10% within the 3 months prior to diagnosis
- No prior radiotherapy to the thorax
- Patient is suitable for lung-board immobilisation
- No chemotherapy received prior to planning PET-CT scan
- Age 18 and over
- Provision of written informed consent
Who cannot join
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
- FEV1 < 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy
RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.
PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.
This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study
Read the detailed description
Pilot Study- Primary Objectives:
- Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
- Rate of PET-CT Scan based treatment delivery
Pilot Study- Secondary Objectives:
-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.
Phase II Study- Primary Objective:
-The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.
Phase II Study- Secondary Objectives:
-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.
- Conditions
- Lung Cancer, Metastatic Cancer
- Being tested
- computed tomography, 3-dimensional conformal radiation therapy, fludeoxyglucose F 18, radiation therapy treatment planning/simulation
- Keywords
- adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, malignant pleural effusion, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Adenocarcinoma of Lung, Pleural Effusion, Malignant, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
3-dimensional conformal radiation therapyRadiation
fludeoxyglucose F 18Radiation
radiation therapy treatment planning/simulationRadiation
| Study group | Role | What they receive |
|---|---|---|
| 3-DCRT | Experimental | Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT Receives: Procedure: computed tomography; Radiation: 3-dimensional conformal radiation therapy; Radiation: fludeoxyglucose F 18; Radiation: radiation therapy treatment planning/simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
Measured: 2016
Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)
Measured: 2016
Secondary outcomes (2)
Acute and long-term radiation-induced toxicity
Measured: 2016
Comparison of dose delivery to organs at risk, according to planning method
Measured: 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMar 2007
- Primary completionDec 2016
Why it stopped: Low levels of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- 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
- Pierre Thirion, MD, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958321
- Sponsor's protocol ID
- CTRIAL-IE (ICORG)06-35
- Other IDs
- CTRIAL-IE (ICORG) 06-35, EU-20925
- Status last verified
- May 2017
- First submitted
- 12 Aug 2009
- Last updated
- 24 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy
- ClinicalTrials.gov ID
- NCT00958321
- Acronym / sponsor ID
- CTRIAL-IE (ICORG)06-35
- Conditions
- Lung Cancer, Metastatic Cancer
- Keywords
- adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, malignant pleural effusion, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low levels of recruitment
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Mar 2007
- Primary completion
- Dec 2016 (actual)
- First posted
- 13 Aug 2009 (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: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.
PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.
This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study
Detailed description
Pilot Study- Primary Objectives:
- Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
- Rate of PET-CT Scan based treatment delivery
Pilot Study- Secondary Objectives:
-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.
Phase II Study- Primary Objective:
-The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.
Phase II Study- Secondary Objectives:
-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3-DCRT | Experimental | Procedure: computed tomography, Radiation: 3-dimensional conformal radiation therapy, Radiation: fludeoxyglucose F 18, Radiation: radiation therapy treatment planning/simulationPatients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
- TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
- Measurable disease
- No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
- Patient suitable for radical 3-DCRT
Key exclusion criteria (2 listed)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
- FEV1 < 1
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 |
|---|---|---|
| computed tomography | Procedure or surgery | 3-DCRT |
| 3-dimensional conformal radiation therapy | Radiation | 3-DCRT |
| fludeoxyglucose F 18 | Radiation | 3-DCRT |
| radiation therapy treatment planning/simulation | Radiation | 3-DCRT |
Primary outcome
Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
Time frame: 2016
Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)
Time frame: 2016
2 secondary outcomes
Acute and long-term radiation-induced toxicity
Time frame: 2016
Comparison of dose delivery to organs at risk, according to planning method
Time frame: 2016
Results and safety
The study was stopped early (reason given: Low levels of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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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.
Pierre Thirion, MD principal investigator
Saint Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing computed tomography, 3-dimensional conformal radiation therapy and fludeoxyglucose F 18 in people with Lung Cancer and Metastatic Cancer, run by Cancer Trials Ireland at 1 site 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 12 inclusion and 2 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: stopped early, as of the sponsor's last update on 24 May 2017. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low levels of recruitment). Results are not available in the source record.
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?
Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot) (time frame: 2016). 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?
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 24 May 2017.