Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)
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|ClinicalTrials.gov Identifier: NCT01166204|
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stage I-III Non-small Cell Lung Cancer||Radiation: Radiotherapy||Phase 2|
Eligible patients (see below) will receive 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 concurrence 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 - vinorelbine
- cisplatin - docetaxel
- cisplatin - etoposide
- cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles
When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD|
|Actual Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
|Experimental: Single group||
- Overall survival [ Time Frame: 2.3 and 5 years ]
- Progression-free survival [ Time Frame: 2.3 and 5 years ]
- Dyspnea (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ]
- Dysphagia (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ]
- Patterns of recurrence [ Time Frame: 2.3 and 5 years ]
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): NCT01166204
|Maastricht, Limburg, Netherlands, 6229 ET|