Non-small Cell Lung Cancer Clinical Trial
Official title:
Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer
Verified date | August 2018 |
Source | Maastricht Radiation Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators group uses an individualised radiation dose approach in which the dose is escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is 69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose) constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the investigators will adapt the treatment by performing a new (PET)-CT at day 12 during radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be increased.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological or cytological proven NSCLC - UICC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment - Performance status 0-2 - IMRT technique Exclusion Criteria: - Not NSCLC of mixed NSCLC and other histologies (e.g. small cell carcinoma) - Stage IV, except for solitary (<6) metastases - Performance status 3 or more |
Country | Name | City | State |
---|---|---|---|
Netherlands | MAASTRO clinic | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients able to receive 69Gy as TTD | 3 months | ||
Secondary | Overall survival | 3 months | ||
Secondary | Progression free survival | 3 months | ||
Secondary | Dyspnea (CTCAE 4.0) | 3 months | ||
Secondary | Dysphagia (CTCAE 4.0) | 3 months | ||
Secondary | Patterns of recurrence | 3 months |
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