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LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC

NCT01795521 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-01-31

No results posted yet for this study

Summary

Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year. Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all cases. The five year survival of NSCLC patients is quite poor (16%), mainly due to patients being diagnosed at advanced stages. However if lung cancer can be detected and treated at an earlier stage the outcome and survival is much more favorable with five year survival rates up to 77%.

The current standard of care for small volume tumors is surgical resection in medically fit patients, consisting in lobectomy or pneumonectomy accompanied by a systematic mediastinal lymph node sampling or lymphadenectomy. For the patient population with small volume disease at early stage surgery offers the potential of local tumor control in up to 96% of the patients.

However, about one quarter of the patients is medically inoperable because of coexisting morbidities or poor general condition, mostly the result of a long smoking history and consecutive chronic Obstructive pulmonary disease (COPD) and coronary artery disease (CAD).

The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment.

Secondary objectives of the study are

* to assess safety of the treatment modality by collecting data about acute and late toxicity
* patterns of local and distant recurrence and relation between the site of local recurrence and the clinical (CTV) and planning target volume (PTV)
* survival and cause of death

Conditions

  • Non-small Cell Lung Cancer Stage I
  • Non-small Cell Lung Cancer Stage II

Interventions

RADIATION

Stereotactic Body Radiotherapy (SBRT)

A form of radiation therapy, where only the primary tumor is targeted and precise stereotactic tumor localization combined with techniques reducing breathing- induced target motion allowed small safety margins. These small volumes are treated with hypo-fractionated, escalated irradiation doses. It's now further developed in multiple clinical and technological aspects e.g. FDG-PET/CT based nodal staging, respiration correlated CT- imaging for target volume definition and image-guided treatment delivery.

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Nestlé Ursula · University Hospital Freiburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Belgium
  • Germany
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795521 on ClinicalTrials.gov