Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients.
Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the local control rate is low and the radiation often causes pneumonitis and/or esophagitis.
To predict to lung damage the mean lung dose can be calculated. This allows us to give a higher total dose to the tumor and to improve the local control rate.
Study hypothesis: It will be safe to administer a radiation dose as high as possible to the tumor, taking into account the mean lung dose, calculated by the treatment planning system.
Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the survival rate as well as the local control rate is low. If chemotherapy treatment is added it leads to a slightly better outcome. The radiotherapy treatment often causes pneumonitis and/or esophagitis. So damage to the normal tissue restricts the radiation dose that can be administered.
However, several studies have shown that higher doses lead to better local control. Furthermore it is evident that the radiotherapy treatment should be given in a short time, preferably the treatment time should not exceed 32 days.
To avoid a higher toxicity the normal tissue has to be spared, but to increase the local control rate the tumor dose must be as high as possible. This dilemma can only be solved by using very sophisticated treatment planning techniques in combination with a biologically superior treatment schedule. This schedule consists of delivering radiation dose twice a day instead of once, thus keeping the overall treatment time as low as possible.
For the whole patient population, the mean lung dose can to a great extend predict the probability for developing radiation pneumonitis and the post-radiotherapy lung function. A logical next step is to determine the dose of radiotherapy on an individualised calculation of the maximum tolerated dose, being defined as the mean lung dose and the spinal cord dose.
The objective of this trial is to investigate whether individualised radiation dose calculation based on a mean lung dose and the constraints of the spinal cord, in combination with an overall treatment time of less than 32 days, and only irradiating the primary tumor and the PET scan positive mediastinal areas is safe.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
escalation of dose (radiotherapy treatment)
Maastircht Radiation Oncology
Maastricht Radiation Oncology
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00181545
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Carcinoma, Non-small-cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Small Cell Lung Carcinoma
A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
Radiotherapy where there is improved dose homogeneity within the tumor and reduced dosage to uninvolved structures. The precise shaping of dose distribution is achieved via the use of computer-controlled multileaf collimators.
CONFORMAL RADIOTHERAPY that combines several intensity-modulated beams to provide improved dose homogeneity and highly conformal dose distributions.
Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should rece...
In this study we try to increase the radiation dose, while reducing or keeping the radiation schedule below 4 weeks. The study hypothesis is that it is feasible to administer hyperfractio...
The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.
Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed stage II...
The purpose of this study is to predict responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer
Especially for non-small cell lung cancer, FDG-PET has in the majority of the patients led to the safe decrease of radiotherapy volumes, enabling radiation-dose escalation and, experimentally, redistr...
PURPOSE: To evaluate the potential of adaptive radiotherapy (ART) for advanced-stage non-small cell lung cancer (NSCLC) in terms of lung sparing and dose escalation. METHODS AND MATERIALS: In 13 patie...
BACKGROUND: The goal of the current study was to investigate the tumor control probability (TCP) of advanced radiotherapy technologies for stage III non-small cell lung cancer (NSCLC) and to evaluate...
PURPOSE: The goal of this work was to investigate the potential of advanced radiation techniques in dose escalation in the radiotherapy (RT) for the treatment of esophageal carcinoma. METHODS: A total...
PURPOSE: To assess feasibility and reproducibility of an Active Breathing Coordinator (ABC) used throughout radical radiotherapy for non-small-cell lung cancer, and compare lung dosimetric parameters...