Adaptive Radiotherapy in Non-small Cell Lung Cancer (NSCLC)
|Non-small Cell Lung Cancer||Other: Radiotherapy and concurrent chemo-therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer|
- Proportion of patients able to receive 69Gy as TTD [ Time Frame: 3 months ]
- Overall survival [ Time Frame: 3 months ]
- Progression free survival [ Time Frame: 3 months ]
- Dyspnea (CTCAE 4.0) [ Time Frame: 3 months ]
- Dysphagia (CTCAE 4.0) [ Time Frame: 3 months ]
- Patterns of recurrence [ Time Frame: 3 months ]
|Actual Study Start Date:||March 2011|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Other: Radiotherapy and concurrent chemo-therapy
Radiotherapy and concurrent chemo-therapy
Eligible patients will receive concurrent chemo-radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/- 1Gy, irrespective of lung function.
Other dose constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy.
In concurrent with chemotherapy, radiotherapy will be delivered as follows:
- First three weeks /30 fractions:twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions.
- Thereafter: once-daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.
In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
Chemotherapy schedules allowed:
- 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.
Concurrent part: (day 1=first day of radiotherapy)
- cisplatin-pemetrexed in non-squamous histologies
Q3 week; 3 cycles
When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin.
In case the TTD(Total Treatment Dose)=69Gy cannot be reached because of a limiting MLD, a FDG-PET-CT will be performed at day 12 during radiotherapy. GTV's (Gross Tmor Volume), CTV's (Clinical Target Volume) and PTV's (Planning Target Volume) will be delineated and a new plan calculated. The endpoint will be the proportion of patients that will receive 69Gy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207063
|Maastricht, Limburg, Netherlands, 6229 ET|