Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

Study summary

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiotherapy (SBRT) and Stereotactic Body Radiotherapy (SBRT)

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 27, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?The Netherlands Cancer Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: The Netherlands Cancer Institute
Interventions being studied: Radiation: Stereotactic Body Radiotherapy (SBRT); Radiation: Stereotactic Body Radiotherapy (SBRT)

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How this study is categorized

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

Disease setting

Metastatic or stage IV→

Treatment approach

Radiation therapy→

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

for group A and B:
Weight loss \< 10% in the last three months.
WHO-performance status ≤ 2
Medical inoperable patients or patients refusing surgery.
Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations. Risk group A specification:
NSCLC (Cytological or histological proven) patients with peripheral tumors \>5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no

Reasons someone may not be able to joinExclusion criteria

, as long as the tumor diameter is \> 5 cm).
Single peripheral lung metastasis in inoperable patients with a diameter of \> 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV \>5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present. Risk group B specification:
Patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung.
In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.
Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap.

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

Study sites

U.S. locations

Beaumont Hospital, Royal OakRoyal Oak, Michigan
Thomas Jefferson University/ Kimmel Cancer CenterPhiladelphia, Pennsylvania
Prinses Margaret HospitalToronto, Ontario
Universitätsklinikum WürzburgWürzburg, Bavaria
NKI-AVLAmsterdam

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 27, 2019. Always confirm current availability with the study team.

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