MAASTRO clinic
Maastricht, Limburg, 6229 ET, Netherlands
NCT Number: NCT01166204
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Maastricht, Limburg, 6229 ET, Netherlands
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:
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:
When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiotherapy
Time frame: 2.3 and 5 years
Time frame: 2.3 and 5 years
Time frame: 2.3 and 5 years
Time frame: 2.3 and 5 years
Time frame: 2.3 and 5 years
Maastricht Radiation Oncology
Other
Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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