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

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. Identifier: NCT01577212
Recruitment Status : Terminated (Lack of accrual)
First Posted : April 13, 2012
Last Update Posted : November 9, 2015
Information provided by (Responsible Party):
Jan Bussink, Radboud University

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

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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

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 ]

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

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

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 identifier (NCT number): NCT01577212

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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

Responsible Party: Jan Bussink, Associate Professor, Radboud University 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    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015

Keywords provided by Jan Bussink, Radboud University:
individualized dose-escalation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms