Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01656460|
Recruitment Status : Completed
First Posted : August 3, 2012
Results First Posted : July 24, 2015
Last Update Posted : July 22, 2020
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Stereotactic radiation Arm 1 Radiation: Stereotactic radiation Arm 2 Radiation: Stereotactic radiation Arm 3 Radiation: Stereotactic radiation Arm 4||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||May 16, 2017|
Experimental: Stereotactic radiation Arm 1
Dose Levels/total Dose
1 16 Gy
Radiation: Stereotactic radiation Arm 1
Dose Levels Dose per Fraction Total Dose
1 8 Gy 16 Gy
Experimental: Stereotactic radiation Arm 2
2 20 Gy
Radiation: Stereotactic radiation Arm 2
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Experimental: Stereotactic radiation Arm 3
3 24 Gy
Radiation: Stereotactic radiation Arm 3
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Experimental: Stereotactic radiation Arm 4
4 28 Gy
Radiation: Stereotactic radiation Arm 4
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656460
|United States, Rhode Island|
|memorial Hospital of Rhode island|
|Pawtucket, Rhode Island, United States, 02860|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Study Chair:||Howard Safran, MD||BrUOG Study Chair|
|Responsible Party:||Dr Thomas DiPetrillo, Prinicipal Investigator, Brown University|
|Other Study ID Numbers:||
|First Posted:||August 3, 2012 Key Record Dates|
|Results First Posted:||July 24, 2015|
|Last Update Posted:||July 22, 2020|
|Last Verified:||July 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases