Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
This study is currently recruiting participants.
Verified April 2013 by Brown University
Sponsor:
Dr Thomas DiPetrillo
Collaborator:
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
Dr Thomas DiPetrillo, Brown University
ClinicalTrials.gov Identifier:
NCT01656460
First received: July 24, 2012
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Radiation: stereotactic |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Brown University:
Primary Outcome Measures:
- early and intermediate toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 18 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Stereotactic radiation | Radiation: stereotactic |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
PATIENT ELIGIBILITY Conditions for Patient Eligibility
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656460
Contacts
| Contact: Kayla Rosati | 401-863-3000 | kayla_rosati@brown.edu |
Locations
| United States, Rhode Island | |
| memorial Hospital of Rhode island | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| Contact: patti wingate 401-729-2225 patti_wingate@mhri.org | |
| Principal Investigator: anthony thomas, MD | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: kayla rosati 401-863-3000 kayla_rosati@brown.edu | |
| Sub-Investigator: jaroslaw hepel, md | |
| Sub-Investigator: howard safran, md | |
| Principal Investigator: thomas dipetrillo, md | |
Sponsors and Collaborators
Dr Thomas DiPetrillo
Memorial Hospital of Rhode Island
More Information
No publications provided
| Responsible Party: | Dr Thomas DiPetrillo, Prinicipal Investigator, Brown University |
| ClinicalTrials.gov Identifier: | NCT01656460 History of Changes |
| Other Study ID Numbers: | BrUOG 259 |
| Study First Received: | July 24, 2012 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Brown University:
|
Lung Cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013