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)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall survival [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
- Dyspnea (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
- Dysphagia (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
- Patterns of recurrence [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166204
|Maastricht, Limburg, Netherlands, 6229 ET|
|Contact: Dirk De Ruysscher, MD, PhD +31 88 44 55 700 firstname.lastname@example.org|
|Contact: Chantal Overhof +31 88 44 55 686 email@example.com|
|Principal Investigator: Dirk De Ruysscher, MD, PhD|