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Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

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

Inclusion 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

- Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.

- Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

early and intermediate toxicity

Outcome Description:

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

Outcome Time Frame:

3 months

Safety Issue:



United States: Food and Drug Administration

Study ID:

BrUOG 259



Start Date:

April 2012

Completion Date:

October 2013

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Lung Neoplasms



Rhode Island HospitalProvidence, Rhode Island  02903
Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860