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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Stage III Non-small Cell Lung Cancer; Individualized Radiation Dose Escalation	Radiation: Individualized dose escalation	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
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)
Study Start Date :	March 2012
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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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:

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

Exclusion Criteria:

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

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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