Clinical trial NCT01656460: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Official title: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Memorial Hospital of Rhode Island
First posted: 2012-08-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: Early and Intermediate Toxicity for Dose Limiting Toxicity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: memorial Hospital of Rhode island
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: BrUOG Study Chair
name: Howard Safran, MD
role: STUDY_CHAIR
References: