CompletedPhase 1 / Phase 2NCT01543672

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

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.

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations5
SponsorThe Netherlands Cancer Institute
01
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)
02
Explore related studies

How this study is categorized

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

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion 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 exclusion 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. Exclusion Criteria: * Patients with central tumors * Pancoast tumors * Prior radiotherapy treatment to the thorax * Patients receiving any systemic treatment during SBRT * Pregnant patients * Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.

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

  • 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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