Lung CancerNCT01656460
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
A study testing Stereotactic radiation Arm 1, Stereotactic radiation Arm 2 and Stereotactic radiation Arm 3 in people with Lung Cancer, run by Dr Thomas DiPetrillo at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer. 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?
- Stereotactic radiation Arm 1, Stereotactic radiation Arm 2 and Stereotactic radiation Arm 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to 16 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)
- Pathologically or cytologically confirmed NSCLC
- Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
- Concurrent chemoradiation to a radiation dose of 50.4 Gy.
- residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:
- Primary tumor <120cc (approximately 6cm diameter).
- Mediastinal/Hilar disease: 1-2 involved regions <60cc (approximately 5cmx3cmx3cm)
- Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
- Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
- ECOG performance status 0 to 2
- Minimum life expectancy of 12 weeks.
- Age older than 18 years.
- Voluntary, signed written informed consent.
- Women of childbearing potential must have a negative pregnancy test
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.
Conditions for Patient Ineligibility (Exclusion)
- Disease progression during or after standard chemoradiation to 50.4 Gy
- Prior thoracic radiation other than the pre-operative radiation not greater than 50.4
- Metastatic disease
- Uncontrolled severe, intercurrent illness.
- Women who are breast-feeding.
- No chemotherapy within 2 weeks from the first SBRT treatment.
- Concurrent anticancer therapy.
- Prior complete resection of all NSCLC.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
memorial Hospital of Rhode island
Pawtucket, Rhode Island, 02860
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
Read the detailed description
This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
- Conditions
- Lung Cancer
- Being tested
- Stereotactic radiation Arm 1, Stereotactic radiation Arm 2, Stereotactic radiation Arm 3, Stereotactic radiation Arm 4
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiation Arm 1Radiation
Dose Levels Dose per Fraction Total Dose
1 8 Gy 16 Gy
Stereotactic radiation Arm 2Radiation
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Stereotactic radiation Arm 3Radiation
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Stereotactic radiation Arm 4Radiation
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiation Arm 1 | Experimental | Dose Levels/total Dose
1 16 Gy Receives: Radiation: Stereotactic radiation Arm 1 |
| Stereotactic radiation Arm 2 | Experimental | 2 20 Gy Receives: Radiation: Stereotactic radiation Arm 2 |
| Stereotactic radiation Arm 3 | Experimental | 3 24 Gy Receives: Radiation: Stereotactic radiation Arm 3 |
| Stereotactic radiation Arm 4 | Experimental | 4 28 Gy Receives: Radiation: Stereotactic radiation Arm 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early and Intermediate Toxicity for Dose Limiting Toxicity
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.
DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Thomas DiPetrillo
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hospital of Rhode Island
- Responsible party
- Sponsor-investigator, Dr Thomas DiPetrillo, Brown University
- Investigators
- Howard Safran, MD, Study chair, BrUOG Study Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656460
- Sponsor's protocol ID
- BrUOG 259
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2012
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
- ClinicalTrials.gov ID
- NCT01656460
- Acronym / sponsor ID
- BrUOG 259
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dr Thomas DiPetrilloUniversity, hospital or other
- Collaborators
- Memorial Hospital of Rhode Island
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Posted 24 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
Detailed description
This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiation Arm 1 | Experimental | Radiation: Stereotactic radiation Arm 1Dose Levels/total Dose 1 16 Gy |
| Stereotactic radiation Arm 2 | Experimental | Radiation: Stereotactic radiation Arm 22 20 Gy |
| Stereotactic radiation Arm 3 | Experimental | Radiation: Stereotactic radiation Arm 33 24 Gy |
| Stereotactic radiation Arm 4 | Experimental | Radiation: Stereotactic radiation Arm 44 28 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 radiation Arm 1Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy | Radiation | Stereotactic radiation Arm 1 |
| Stereotactic radiation Arm 2Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy | Radiation | Stereotactic radiation Arm 2 |
| Stereotactic radiation Arm 3Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy | Radiation | Stereotactic radiation Arm 3 |
| Stereotactic radiation Arm 4Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy | Radiation | Stereotactic radiation Arm 4 |
Primary outcome
Early and Intermediate Toxicity for Dose Limiting Toxicity
Time frame: 3 months
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Howard Safran, MD study chair
BrUOG Study Chair
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiation Arm 1, Stereotactic radiation Arm 2 and Stereotactic radiation Arm 3 in people with Lung Cancer, run by Dr Thomas DiPetrillo at 2 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?
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 22 Jul 2020. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Early and Intermediate Toxicity for Dose Limiting Toxicity (time frame: 3 months). 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 22 Jul 2020.