View clinical trials related to Thoracic Tumor.
Filter by:Rationale: Radiation-induced cardiac and pulmonary toxicity after treatment for intra-thoracic tumors is a clinically relevant problem, which may jeopardize the benefit of (neo-adjuvant) (chemo) radiotherapy. Although cure rates are rising since the introduction of neo-adjuvant chemoradiation (neo-CRT) as current standard treatment for esophageal cancer (EC), recent studies showed that there is a substantial risk of non-cancer treatment-related death in these patients. Furthermore, this risk is underestimated as the cause of death of many patients remains unknown, since the distinction between tumor related and non-cancer related death can be difficult. Cardiac and pulmonary toxicity and its interaction as seen in pre-clinical studies might explain for these unknown deaths as suggested in several clinical studies. Clinical imaging studies performed shortly after treatment showed changes in different cardiac function parameters, all related to radiation dose parameters. Systematic imaging studies analysing subclinical toxicities at longer follow up have never been performed, most probably because of poor survival rates. However, identification of the magnitude of (subclinical) cardiopulmonary toxicity, by performing several cardiopulmonary function tests, is essential in this patient group as this toxicity is most likely the cause of the increased mortality after thoracic radiotherapy. For future perspectives, these results can be used to select the best diagnostic methods for a prospective cohort study to develop prediction tools for cardiopulmonary toxicity.. Objective: The main objective of this study is to determine the most suitable diagnostic test to identify cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection. Furthermore, we want to estimate the difference in cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection compared to EC survivors who were treated with surgical resection alone. Study design: Cross-sectional pilot study Study population: 40 EC patients who were treated with curative intent by esophageal resection with or without neo-CRT Intervention (if applicable): Not applicable. Main study parameters/endpoints: As this is an exploratory pilot study to determine the most suitable diagnostic tests for future studies, there will be several endpoints related to (sub)clinical cardiopulmonary dysfunction. Signs of myocardial ischemia, systolic or diastolic dysfunction, rhythm and valve disorders, pericardial effusion and fibrosis, myocardial fibrosis, focal wall motion disorders and coronary calcifications will be analyzed. The cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection will be compared to cardiopulmonary (dys)function in EC survivors treated with surgical resection alone. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Several tests will be performed at one time point, 5-10 years after given treatment. If the findings of the test indicate cardiovascular complications, the patient will be referred to the cardiologist for further analysis and/or preventive measures. As one of the tests, cardiac MRI, including gadolinium (Dotarem 0.2 mmol/kg) enhancement will be performed. Potential side effects of gadolinium include brief headache, nausea (feeling sick) and dizziness for a brief time following the injection. Allergic reactions are rare. Furthermore, a cardiac CT scan will be performed with a total radiation exposure of 0.6 mSv (less than a third of the annual background radiation dose), the risks will be minimal.
Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer, and (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for the treatment to be effective. However, this accuracy is compromised by tumour and organ motion. Radiotherapy treatment planning is typically performed on a planning-CT scan recorded several days prior to commencement of radiotherapy. Inter-fraction set up variations and organ motion during treatment can lead to differences between the calculated dose distribution on the planning-CT and the radiation dose actually received by the tumour and normal organs. Accurate assessment of these effects is essential to determine optimal margins in order to irradiate the tumour adequately while minimizing the dose to the organs at risk (OARs). In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non) Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables marked reductions of the radiation dose to the OARs and thus decreasing the risk of radiation induced cardiac and lung toxicity. However, for PBT using pencil beam scanning (PBS), knowledge of tumour and organ motion will be even more important. The potential major advantages of PBS for tumours in the thoracic region are challenged by the respiratory motion of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors and inter- and intra-fraction organ motion cause geometric displacement of the tumours and normal tissues, which can cause underdosage of the target volumes and overdosage of the organs at risk. Furthermore, it can result in changes in tissue densities in the beam path, which can alter the position of the Bragg peaks and lead to distorted dose distributions. If pencil beam scanning techniques are used to treat moving tumours, there is interplay between the dynamic pencil beam delivery and target motion. This phenomenon can cause additional deterioration of the delivered dose distribution, usually manifesting as significant local under and/or over dosage. It is therefore essential to incorporate motion-related uncertainties during treatment planning. The main objective of this study is to evaluate the impact of inter-fraction tumour and organ motion - while taking into account intra-fraction movements appropriately - on photon and proton radiotherapy treatment planning in order to yield robust intensity modulated photon and/or proton treatment plans. Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation for moving tumours on photon and proton radiotherapy treatment plans in order to create robust intensity modulated photon- and/or proton treatment plans. Study design: Pilot-study (80 patients). Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with radiotherapy (with or without chemotherapy) with curative intent. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose, MHD) and the lungs (mean lung dose, MLD). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat planning CT scans in treatment position without contrast agents in order to evaluate the impact of inter-fraction tumour and organ motion. Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the intra-fraction motion. The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10 x 7mSv results in an effective dose < 250mSv) compared to the therapeutic radiation dose (40-60Gy). The risks are therefore negligible and the burden is low.