N/A N=12 Treatment

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01656460 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jul 2015

Primary outcome: Primary: Early and Intermediate Toxicity for Dose Limiting Toxicity — 0; 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stereotactic radiation Arm 1 (Radiation); Stereotactic radiation Arm 2 (Radiation); Stereotactic radiation Arm 3 (Radiation); Stereotactic radiation Arm 4 (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dr Thomas DiPetrillo
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Early and Intermediate Toxicity for Dose Limiting Toxicity	0; 0; 0; 0	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01656460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.