Individualized Dose Prescription in Advanced Stage Lung Cancer Patients Using Modern (Chemo)Radiotherapy (IDEAL-VMAT)

This study has been terminated.

(Lack of accrual)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01577212

First Posted: April 13, 2012

Last Update Posted: November 9, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Jan Bussink, Radboud University

Purpose

The aim of this present study is to test the feasibility and toxicity of individualized hypofractionated radiotherapy, and to report outcome data. In case this phase II trial has favorable results, a phase II/III trial on maximally tolerable, individualized, hypofractionated radiotherapy within a shorter overall-treatment time is aimed for.

Condition	Intervention	Phase
Stage III Non-small Cell Lung Cancer Individualized Radiation Dose Escalation	Radiation: Individualized dose escalation	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Individualized Dose Escalation for Non-small Cell Lung Cancer (NSCLC) Using Volumetric Modulated Arc Therapy (VMAT)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Jan Bussink, Radboud University:

Primary Outcome Measures:

Pulmonary toxicity grade 2-4 [ Time Frame: 2 years ]
Esophageal toxicity grade 2-4 [ Time Frame: 2 years ]

Secondary Outcome Measures:

Increase in tumor control probability (TCP) [ Time Frame: 2 years ]
Local-regional failure [ Time Frame: 2 years ]
Progression-free survival [ Time Frame: 2 years ]
Quality of life [ Time Frame: 2 years ]
Overall survival [ Time Frame: 2 years ]


Enrollment:	6
Study Start Date:	March 2012
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Individualized dose escalation Individualized dose escalation on the basis of the dose to the organs at risk.	Radiation: Individualized dose escalation Individualized dose escalation on the basis of the maximally tolerable dose to organs at risk - lung, esophagus, spinal cord, heart, brachial plexus

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Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed stage IIIA/B NSCLC (excluding pleural effusion and mixed pathology)
Irresectable disease (as assessed by multidisciplinary team) or patient refusing surgery
Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating center
Proposed treatment consists of radiotherapy alone or concurrent chemoradiation
WHO performance status 0 or 1
Adequate respiratory function: FEV1 ≥ 1.5 L and DLCO > 40%, predicted on baseline pulmonary function tests
Age ≥ 18 years, no upper age limit
Estimated life expectancy of more than 6 months
Patient is available for follow-up
Written informed consent obtained

Exclusion Criteria:

Clinically diagnosed NSCLC
Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
Prior thoracic radiotherapy
Proposed treatment consist of sequential chemoradiation
Prior lobectomy / pneumonectomy
Prior chemotherapy using gemcitabine or bleomycine
Superior sulcus tumors if the brachial plexus is within the high-dose volume
Medically unstable (e.g., ischaemic heart disease, esophageal disorders)
Pregnancy
Connective tissue disorders
Abnormal kidney function interfering with administration of iv contrast agent (GFR<60)
Uncontrolled diabetes mellitus hampering 18FDG-PET
Inability to comply with protocol or trial procedures

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577212

Locations


Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB

Sponsors and Collaborators

Radboud University

Investigators


Principal Investigator:	Jan Bussink, MD PhD	Radboud University
Principal Investigator:	Esther GC Troost, MD PhD	Radboud University
Principal Investigator:	Robin Wijsman, MD	Radboud University
Principal Investigator:	Aswin L Hoffmann, MSc	Maastro Clinic, The Netherlands
Principal Investigator:	Lioe-Fee de Geus-Oei, MD PhD	Radboud University

More Information


Responsible Party:	Jan Bussink, Associate Professor, Radboud University
ClinicalTrials.gov Identifier:	NCT01577212 History of Changes
Other Study ID Numbers:	CMO 2011/345 NL nr 35536.091.11 ( Registry Identifier: CCMO )
First Submitted:	March 16, 2012
First Posted:	April 13, 2012
Last Update Posted:	November 9, 2015
Last Verified:	November 2015

Keywords provided by Jan Bussink, Radboud University:


stage III NSCLC (chemo)radiotherapy individualized dose-escalation

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site	Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms

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