Clinical trial · Interventional
Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients.
Individualised Radiation Dose Determination on Basis of Normal Tissue Dose Constraints in Patients With Non-Small-Cell Lung Cancer: A Phase I Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the local control rate is low and the radiation often causes pneumonitis and/or esophagitis. To predict to lung damage the mean lung dose can be calculated. This allows us to give a higher total dose to the tumor and to improve the local control rate. Study hypothesis: It will be safe to administer a radiation dose as high as possible to the tumor, taking into account the mean lung dose, calculated by the treatment planning system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| escalation of dose (radiotherapy treatment) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- incidence of steroid dependent (grade 2 or more) radiation pneumonitis 6 months after the last radiotherapy dose.
Secondary outcomes (7)
- measure
- incidence of radiation pneumonitis according to the location of the primary tumour
- measure
- acute esophagitis
- measure
- FEV1 6 months after radiotherapy
- measure
- DLCO 6 months after radiotherapy
- measure
- late esophagitis, 6 months after radiotherapy
- measure
- tumor response, 70 days post chest radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven non-small cell lung cancer * UICC stage I-III * WHO performance status 0-2 * Less than 10 % weight loss the last 6 months * In case of previous chemotherapy, radiotherapy can start after a minimum of 21 days after the last chemotherapy course * Reasonable lung function: FEV1 ³ 60 % of the predicted value * No recent ( \< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction) * No active peptic oesophagitis * Life expectancy more than 6 months * Measurable cancer * Willing and able to comply with the study prescriptions * 18 years or older * Not pregnant and willing to take adequate contraceptive measures during the study * Have given written informed consent before patient registration * No previous radiotherapy to the chest Exclusion Criteria: * Not non-small cell histology, e.g. mesothelioma, lymphoma * Mixed pathology, e.g. non-small cell plus small cell cancer * Malignant pleural or pericardial effusion * Concurrent chemotherapy with radiation * History of prior chest radiotherapy * Recent ( \< 3 months) myocardial infarction * Uncontrolled infectious disease * Distant metastases (stage IV) * Patients with active peptic oesophagitis in the last year. * Less than 18 years old * Pregnant or not willing to take adequate contraceptive measures during the study
References
Publications (0)
Data not yet available