Individualized Dose Prescription in Advanced Stage Lung Cancer Patients Using Modern (Chemo)Radiotherapy (IDEAL-VMAT)
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ClinicalTrials.gov Identifier: NCT01577212 |
Recruitment Status
:
Terminated
(Lack of accrual)
First Posted
: April 13, 2012
Last Update Posted
: November 9, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stage III Non-small Cell Lung Cancer Individualized Radiation Dose Escalation | Radiation: Individualized dose escalation | Phase 2 |

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 |

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

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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:
- 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

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
Netherlands | |
Radboud University Nijmegen Medical Centre | |
Nijmegen, Netherlands, 6500 HB |
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 |
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 Key Record Dates |
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 |