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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | June 29, 2009 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
incidence of steroid dependent (grade 2 or more) radiation pneumonitis 6 months after the last radiotherapy dose. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00181545 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients. | ||||
| Official Title ICMJE | Individualised Radiation Dose Determination on Basis of Normal Tissue Dose Constraints in Patients With Non-Small-Cell Lung Cancer: A Phase I Study | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study | ||||
| Condition ICMJE | Non-Small-Cell Lung Carcinoma | ||||
| Intervention ICMJE | Procedure: escalation of dose (radiotherapy treatment) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00181545 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P04.1338L, MAASTRO 04-06 | ||||
| Study Sponsor ICMJE | Maastricht Radiation Oncology | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Maastricht Radiation Oncology | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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