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

Dr Thomas DiPetrillo

Status: Completed

Conditions: Lung Cancer

Treatments: Radiation: Stereotactic radiation Arm 4; Radiation: Stereotactic radiation Arm 3; Radiation: Stereotactic radiation Arm 2; Radiation: Stereotactic radiation Arm 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01656460

BrUOG 259

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Stereotactic radiation Arm 1

Experimental group

Description:

Dose Levels/total Dose 1 16 Gy

Treatment:

Radiation: Stereotactic radiation Arm 1

Stereotactic radiation Arm 2

Experimental group

Description:

2 20 Gy

Treatment:

Radiation: Stereotactic radiation Arm 2

Stereotactic radiation Arm 3

Experimental group

Description:

3 24 Gy

Treatment:

Radiation: Stereotactic radiation Arm 3

Stereotactic radiation Arm 4

Experimental group

Description:

4 28 Gy

Treatment:

Radiation: Stereotactic radiation Arm 4