Clinical trial · Interventional
Individualized Dose Prescription in Advanced Stage Lung Cancer Patients Using Modern (Chemo)Radiotherapy
Individualized Dose Escalation for Non-small Cell Lung Cancer (NSCLC) Using Volumetric Modulated Arc Therapy (VMAT)
NCT01577212CI-TRIAL-00019735IDEAL-VMATterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Individualized Radiation Dose Escalation | — | UNRESOLVED | — |
| Stage III Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized dose escalation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Individualized dose escalation
- description
- Individualized dose escalation on the basis of the dose to the organs at risk.
- interventionNames
- Radiation: Individualized dose escalation
Primary outcomes (2)
- measure
- Pulmonary toxicity grade 2-4
- timeFrame
- 2 years
- measure
- Esophageal toxicity grade 2-4
- timeFrame
- 2 years
Secondary outcomes (5)
- measure
- Increase in tumor control probability (TCP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.