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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Jan Bussink, Radboud University
ClinicalTrials.gov Identifier:
NCT01577212
First received: March 16, 2012
Last updated: April 22, 2012
Last verified: April 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Pulmonary toxicity grade 2-4 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Esophageal toxicity grade 2-4 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increase in tumor control probability (TCP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Local-regional failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577212

Contacts
Contact: Jan Bussink, MD PhD +31 24 36 ext 13665 j.bussink@rther.umcn.nl
Contact: Robin Wijsman, MD +31 24 81 ext 87182 r.wijsman@rther.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Jan Bussink, MD PhD    +31 24 36 ext 13665    j.bussink@rther.umcn.nl   
Principal Investigator: Jan Bussink, MD PhD         
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

No publications provided

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
Study First Received: March 16, 2012
Last Updated: April 22, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014