Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients.
|ClinicalTrials.gov Identifier: NCT00181545|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 30, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Procedure: escalation of dose (radiotherapy treatment)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Individualised Radiation Dose Determination on Basis of Normal Tissue Dose Constraints in Patients With Non-Small-Cell Lung Cancer: A Phase I Study|
|Study Start Date :||December 2004|
|Primary Completion Date :||May 2008|
|Study Completion Date :||May 2008|
- incidence of steroid dependent (grade 2 or more) radiation pneumonitis 6 months after the last radiotherapy dose.
- incidence of radiation pneumonitis according to the location of the primary tumour
- acute esophagitis
- FEV1 6 months after radiotherapy
- DLCO 6 months after radiotherapy
- late esophagitis, 6 months after radiotherapy
- tumor response, 70 days post chest radiotherapy
- quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181545
|Maastircht Radiation Oncology|
|Heerlen, Limburg, Netherlands, 6411 PC|
|Principal Investigator:||Dirk De Ruysscher, PHD||Maastricht Radiation Oncology (MAASTRO clinic)|