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CompletedNot applicableNCT01656460
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic radiation Arm 1 and Stereotactic radiation Arm 2

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 22, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Dr Thomas DiPetrillo

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Dr Thomas DiPetrillo
Interventions being studied
Radiation: Stereotactic radiation Arm 1; Radiation: Stereotactic radiation Arm 2; Radiation: Stereotactic radiation Arm 3; Radiation: Stereotactic radiation Arm 4
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • memorial Hospital of Rhode islandPawtucket, Rhode Island
  • Rhode Island HospitalProvidence, Rhode Island

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2020. Always confirm current availability with the study team.

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