Stage IIA Non-small Cell Lung CancerPhase 1NCT01711697
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing stereotactic body radiation therapy, carboplatin and paclitaxel in people with Stage IIA Non-small Cell Lung Cancer and Stage IIB Non-small Cell Lung Cancer, run by Emory University at 4 sites in United States.
Trial summary
This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
- What is being tested?
- stereotactic body radiation therapy, carboplatin and paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Sep 2012to 31 May 2022
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven NSCLC, within 8 weeks prior to patient registration
- Unresectable disease
- Clinical stage Tx, T1-T4, N1-3, M0
- Karnofsky performance status (KPS) ≥ 70
- Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease
- The primary tumor may not be larger than 8 cm in maximum dimension
Show all 11Show fewer
- If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
- Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station
- Pretreatment brain CT with contrast or brain MRI to rule out metastases
- Pathologic assessment of the mediastinum to document involved nodal stations
- All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration
Who cannot join
- Prior history of lung cancer
- Pregnancy
- Prior history of radiation to the chest
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Siteman Cancer Center - Washington University
St Louis, Missouri, 63110
About this study
This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.
Read the detailed description
PRIMARY OBJECTIVE:
To test the safety and tolerability of an alternative fractionation regimen in locally advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be determined.
SECONDARY OBJECTIVES:
- To assess local control.
- To assess distant metastasis and patterns of failure.
- To assess overall survival at 1 and 2 years.
OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
After completion of study treatment, patients are followed up for 5 years.
- Conditions
- Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- Being tested
- stereotactic body radiation therapy, carboplatin, paclitaxel, radiation therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo SBRT
carboplatinDrug
Also called Carboplat, CBDCA, JM-8, Paraplat
paclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy, carboplatin, paclitaxel, SBRT) | Experimental | Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart. Receives: Radiation: stereotactic body radiation therapy; Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)
Measured: Up to 1 year
Acute toxicities associated with this regimen using CTCAE v.4
Crude rates of grade 3 and greater acute toxicities will be reported.
Measured: Up to 90 days
Late toxicities associated with this regimen using CTCAE v.4
Crude rates of grade 3 and greater late toxicities will be reported.
Measured: After 90 days
Secondary outcomes (6)
Local control
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Measured: Up to 5 years
Distant metastasis
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Measured: Up to 5 years
Patterns of failure
Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.
Measured: Up to 5 years
Overall survival
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Measured: At 1 year
Overall survival
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Measured: At 2 years
Overall survival
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start4 Sep 2012
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIA Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University Siteman Cancer Center
- Responsible party
- Principal investigator, Kristin Higgins, MD, Emory University
- Investigators
- Kristin Higgins, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711697
- Sponsor's protocol ID
- IRB00056552
- Other IDs
- NCI-2012-01934, RAD2179-12
- Status last verified
- Jun 2021
- First submitted
- 18 Oct 2012
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01711697
- Acronym / sponsor ID
- IRB00056552
- Conditions
- Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Washington University Siteman Cancer Center
- Study start
- 4 Sep 2012 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 22 Oct 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.
This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.
Detailed description
PRIMARY OBJECTIVE:
To test the safety and tolerability of an alternative fractionation regimen in locally advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be determined.
SECONDARY OBJECTIVES:
- To assess local control.
- To assess distant metastasis and patterns of failure.
- To assess overall survival at 1 and 2 years.
OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
After completion of study treatment, patients are followed up for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy, carboplatin, paclitaxel, SBRT) | Experimental | Radiation: stereotactic body radiation therapy, Drug: carboplatin, Drug: paclitaxel, Radiation: radiation therapyPatients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy proven NSCLC, within 8 weeks prior to patient registration
- Unresectable disease
- Clinical stage Tx, T1-T4, N1-3, M0
- Karnofsky performance status (KPS) ≥ 70
- Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease
Key exclusion criteria (3 listed)
- Prior history of lung cancer
- Pregnancy
- Prior history of radiation to the chest
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 |
|---|---|---|
| stereotactic body radiation therapyAlso: SBRT, stereotactic radiation therapy, stereotactic radiotherapyUndergo SBRT | Radiation | Treatment (radiation therapy, carboplatin, paclitaxel, SBRT) |
| carboplatinAlso: Carboplat, CBDCA, JM-8, Paraplat | Drug | Treatment (radiation therapy, carboplatin, paclitaxel, SBRT) |
| paclitaxelAlso: Anzatax, Asotax, TAX, Taxol | Drug | Treatment (radiation therapy, carboplatin, paclitaxel, SBRT) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Treatment (radiation therapy, carboplatin, paclitaxel, SBRT) |
Primary outcome
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)
Time frame: Up to 1 year
Acute toxicities associated with this regimen using CTCAE v.4
Time frame: Up to 90 days
Crude rates of grade 3 and greater acute toxicities will be reported.
Late toxicities associated with this regimen using CTCAE v.4
Time frame: After 90 days
Crude rates of grade 3 and greater late toxicities will be reported.
6 secondary outcomes
Local control
Time frame: Up to 5 years
Distant metastasis
Time frame: Up to 5 years
Patterns of failure
Time frame: Up to 5 years
Overall survival
Time frame: At 1 year
Overall survival
Time frame: At 2 years
Overall survival
Time frame: At 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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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.
Kristin Higgins, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stereotactic body radiation therapy, carboplatin and paclitaxel in people with Stage IIA Non-small Cell Lung Cancer and Stage IIB Non-small Cell Lung Cancer, run by Emory University at 4 sites in United States.
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 11 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: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4) (time frame: Up to 1 year). The study lists 3 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 23 Jun 2021.