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TerminatedNot applicableNCT00852644
Official study title

Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Study summary

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II 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 studiedcomputed tomography and fludeoxyglucose F 18

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 11, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Boston Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Boston Medical Center
Interventions being studied
Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery
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
Early-stage or resectable→
Treatment approach
Radiation therapy→Surgery→
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
  • DISEASE CHARACTERISTICS:
  • Histologically confirmed non-small cell lung cancer
  • Stage I or II disease (T1-3, N0, M0)
  • T2 or T3 tumor ≤ 5 cm
  • No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
  • Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
  • Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status PATIENT CHARACTERISTICS:
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Reasons someone may not be able to joinExclusion criteria
  • No history of contrast allergy
  • No psychological issues that would preclude the completion of study treatment PRIOR CONCURRENT THERAPY:
  • No prior radiotherapy or chemotherapy
  • No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 \[FDG\]-avid or measure \> 1 cm in short axis diameter on CT scan)
  • No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)

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

  • Boston University Cancer Research CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 11, 2018. Always confirm current availability with the study team.

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