A Phase 2 interventional study of Radiotherapy in Stage I-III Non-small Cell Lung Cancer, sponsored by Maastricht Radiation Oncology. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.
Sponsored by Maastricht Radiation Oncology · Phase 2, Interventional, and Treatment
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.
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:
Concurrent part: (day 1 = first day of radiotherapy)
When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Maastricht Radiation Oncology is the lead sponsor of 104 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: Radiotherapy
Radiotherapy
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
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Maastricht Radiation Oncology