An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT01711697 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 22, 2012
Last Update Posted
: February 14, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Radiation: stereotactic body radiation therapy Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | February 2019 |
Estimated Study Completion Date : | February 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (radiation therapy, carboplatin, paclitaxel, 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.
|
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
Drug: carboplatin
Other Names:
Drug: paclitaxel
Other Names:
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
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- 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.
- Local control [ Time Frame: Up to 5 years ]Will be calculated for the entire cohort using Kaplan-Meier methodology.
- Distant metastasis [ Time Frame: Up to 5 years ]Will be calculated for the entire cohort using Kaplan-Meier methodology.
- Patterns of failure [ Time Frame: Up to 5 years ]Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.
- Overall survival [ Time Frame: At 1 year ]Will be calculated for the entire cohort using Kaplan-Meier methodology.
- Overall survival [ Time Frame: At 2 years ]Will be calculated for the entire cohort using Kaplan-Meier methodology.
- Overall survival [ Time Frame: At 5 years ]Will be calculated for the entire cohort using Kaplan-Meier methodology.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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
- 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
Exclusion Criteria:
- Prior history of lung cancer
- Pregnancy
- Prior history of radiation to the chest

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): NCT01711697
United States, Georgia | |
Grady Health System | |
Atlanta, Georgia, United States, 30303 | |
Emory University Hospital Midtown | |
Atlanta, Georgia, United States, 30308 | |
Emory University Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 | |
United States, Missouri | |
Siteman Cancer Center - Washington University | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Kristin Higgins, MD | Emory University |
Responsible Party: | Kristin Higgins, MD, Principal Investigator, Emory University |
ClinicalTrials.gov Identifier: | NCT01711697 History of Changes |
Other Study ID Numbers: |
IRB00056552 NCI-2012-01934 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) RAD2179-12 ( Other Identifier: Winship Cancer Institute ) |
First Posted: | October 22, 2012 Key Record Dates |
Last Update Posted: | February 14, 2018 |
Last Verified: | February 2018 |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Paclitaxel Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |