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

NCT01795521 | Unknown Phase 2 DMC

• 2 other identifiers: EORTC-22113-081132012-000415-83
• Study Type: interventional
• Target: 39
• Locations: 4 countries
• Sites: 6

Brief 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

Keywords

NSCLC, SBRT, PET, Medically Inoperable

Outcome Measures

Primary Outcomes (1)

• Effectiveness of SBRT in early stage centrally located tumors, ≤ 7 cm

  freedom from local progression rate at 3 years

Study Arms (1)

Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

All eligible patients will be offered Stereotactic Body Radiotherapy using Four-dimensional computed tomography (4D-CT) planning (as a minimum), delivering a dose of 60 Gy in 8 fractions of 7.5 Gy on alternate days over a planned treatment time of 2.5 weeks

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

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.

Also known as: Stereotactic Ablative Body Radiotherapy (SABR)

Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of non-small cell lung cancer (NSCLC), either confirmed by histology or cytology
• Patient deemed medically inoperable after assessment in a multimodality tumor board or refusing surgery
• Tumor size \< 5 cm, or 5-7 cm (strict separate stopping rules will be applied for the latter population)
• Central tumor location i.e. tumor in or abutting a zone within 2 cm of the proximal bronchial tree or other parts of the mediastinum, eligibility of each case underlying expert review
• N0 tumors
• T3 tumors only if: not within the mediastinum and not abutting the oesophagus and only one lesion
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Age ≥ 18 years
• Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Before patient registration, written informed consent must be given according to International Conference on Harmonization /Good Clinical Practice (ICH/GCP), and national/local regulations

You may not qualify if:

• No prior RT of chest and/or mediastinum
• No chemotherapy and/or targeted treatment within 3 months before the onset of RT

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (6)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

U.Z. Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

UniversitaetsSpital Zurich

Zurich, 8091, Switzerland

Location

Royal Marsden Hospital - Sutton, Surrey

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.

  PMID: 26104945 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nestlé Ursula

  University Hospital Freiburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: August 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

CH (1); BE (2); DE (2); GB (1)