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

NCT ID: NCT01656460

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-05-16

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

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic radiation Arm 1

Dose Levels/total Dose

1 16 Gy

Group Type: EXPERIMENTAL

Stereotactic radiation Arm 1

Intervention Type: RADIATION

Dose Levels Dose per Fraction Total Dose

1 8 Gy 16 Gy

Stereotactic radiation Arm 2

2 20 Gy

Group Type: EXPERIMENTAL

Stereotactic radiation Arm 2

Intervention Type: RADIATION

Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy

Stereotactic radiation Arm 3

3 24 Gy

Group Type: EXPERIMENTAL

Stereotactic radiation Arm 3

Intervention Type: RADIATION

Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy

Stereotactic radiation Arm 4

4 28 Gy

Group Type: EXPERIMENTAL

Stereotactic radiation Arm 4

Intervention Type: RADIATION

Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy

Interventions

Stereotactic radiation Arm 1

Dose Levels Dose per Fraction Total Dose

1 8 Gy 16 Gy

Intervention Type: RADIATION

Stereotactic radiation Arm 2

Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy

Intervention Type: RADIATION

Stereotactic radiation Arm 3

Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy

Intervention Type: RADIATION

Stereotactic radiation Arm 4

Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

Dr Thomas DiPetrillo

OTHER

Sponsor Role: lead

Responsible Party

Dr Thomas DiPetrillo

Prinicipal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Howard Safran, MD

Role: STUDY_CHAIR

BrUOG Study Chair

Locations

memorial Hospital of Rhode island

Pawtucket, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BrUOG 259

Identifier Type: -

Identifier Source: org_study_id