To define the recommended phase II mean*lung dose (MLD) to treat peripheral stage II or III NSCLC using SABR for the primary tumor and CFRT for the mediastinal lymph nodes while given concurrent chemotherapy.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mean lung dose that is associated with a 15% probability of a dose limiting
toxicity, defined according to the CTCAE v4.03: radiation pneumonitis grade >= 3
and radiation induced dyspnea grade >= 3.
Secondary outcome
To describe toxic effects of the Hybrid treatment
. To assess the overall treatment time
. Evaluation of local control
. Evaluation of regional control
. Evaluation of overall survival
. Evaluation of local effect on normal tissue changes
Background summary
In locally advanced NSCLC local control with Conventional Fractionated
Radiotherapy (CFRT) is poor, with therapy predominantly failing at the primary
tumor site. New strategies such as accelerated hyperfractionated radiotherapy
(CHART) and concurrent chemoradiation result in increased local control- and
overall survival-rates, at the cost of increased toxicity. Both retrospective
as prospective studies report remarkable high local control rates using
Stereotactic Ablative Radiotherapy (SABR) with low toxicity. The combination of
SABR and CFRT has not been explored thus far. Allowing these patients to be
treated with SABR for their primary tumor and CFRT for the lymph node
metastases, while receiving concurrent chemoradiation, it is hypothesized that
local control and overall survival will increase without an increase of overall
treatment time (OTT)
Study objective
To define the recommended phase II mean*lung dose (MLD) to treat peripheral
stage II or III NSCLC using SABR for the primary tumor and CFRT for the
mediastinal lymph nodes while given concurrent chemotherapy.
Study design
Phase I study with 15 patients
Intervention
3-5 fractions of Stereotactic Ablative radiotherapy combined with conventionale
radiotherapy and chemotherapy
Study burden and risks
The number of radiation fractions does not alter and therefore here is hardly
any extra burden towards the patient. The radiation fraction will take a little
longer when SABR is given. Fourty five minutes instead of 15 min (3 times)
A slight increase of lung toxicity like radiation pneumonitis and dyspnea is
possible, compared to the standard treatment. But also a slight increase of
local control and survival might occur.
The extra SPECT/CT scans (3 x) and PET/CT scan (1x) will give a very low extra
radiation dose compared to the radiation treatment. These clinical
investigations will be combined as much as possible.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm). 
• WHO-performance status <= 2 (Appendix B)
• Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine (section 6.3)
• FEV1 and DLCO > 40 % of the age-adjusted normal value
o Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 5.5 mmol/L.
o Hepatic: bilirubin <= 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) <= 3.0 × ULN.
o Renal: calculated creatinine clearance (CrCl) >= 45 ml/min based on the original weight based Cockcroft and Gault formula.
• Before patient registration, written informed consent must be given according to GCP and national regulations
Exclusion criteria
• Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura. 
• Patients that receive sequential chemoradiotherapy or radiotherapy only. 
• Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03) 
• Patients with Pancoast tumors
• Pregnant women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002392-33-NL |
| CCMO | NL40244.031.12 |