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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656460
• Other study ID #: BrUOG 259
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: May 16, 2017

Study information

• Verified date: July 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 16, 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Stereotactic radiation Arm 1
Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
• Stereotactic radiation Arm 2
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
• Stereotactic radiation Arm 3
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
• Stereotactic radiation Arm 4
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy

Locations

Country	Name	City	State
United States	memorial Hospital of Rhode island	Pawtucket	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Dr Thomas DiPetrillo	Memorial Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early and Intermediate Toxicity for Dose Limiting Toxicity	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. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.; DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.	3 months