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Dose Escalation by Boosting Radiation Dose in Stage II and III Non Small Cell Lung Cancer (NSCLC): a Phase II Trial

2014-08-27 03:17:33 | BioPortfolio

Summary

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 receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost.

Description

Background Increasing the radiation dose can lead to better results. Using IMRT it is possible to make inhomogeneous dosisdivisions so a part of the radiation area can receive a higher dose. IMRT is being used as a standard for some years in patients which are being radiated for lung carcinoma.

Recent investigations show that the primary tumor in the lung is the place

where lung cancer recur most frequently and much less in the lymph glands in the mediastinum. From the part of the primary tumor with the highest activity on the PET-scan* (Positron Emission Tomography) the chance that de cancer recurs is higher than in the part of the tumor that shows low or no activity on the PET.

Because it is not clear if the organs in the area between the lungs can bare a higher radiation dose safely, we ensure that these vulnerable organs receive a radiation dose of which we are sure it is safe.

Aim of the investigation We would like to increase ("boost") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal feasable dose which, according to the normal tissue tolerance models, can be given safely. The question is on which area we can best increase the radiation dose. Therefore we randomize a group of patients between a boost on the whole tumor and a group patients that receive a boost on part of the lung tumor. The area that receives the higher dose will be assigned by lot. All patients will be radiated 24 times. The dose increasement takes place by a so called integrated boost.

Population Patients with a non-small cell inoperable lung carcinoma, stage I and II which will be treated with chemotherapy and radiotherapy or radiotherapy alone and have signed the consent form.

All patients must have received a complete radiotherapy planning before the randomisation in order to see if a higher dose can be given safely.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

NSCLC

Intervention

Radiotherapy

Location

MAASTRO clinic
Maastricht
Limburg
Netherlands
6229 ET

Status

Recruiting

Source

Maastricht Radiation Oncology

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:33-0400

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The total amount of radiation absorbed by tissues as a result of radiotherapy.

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.

Radiotherapy where cytotoxic radionuclides are linked to antibodies in order to deliver toxins directly to tumor targets. Therapy with targeted radiation rather than antibody-targeted toxins (IMMUNOTOXINS) has the advantage that adjacent tumor cells, which lack the appropriate antigenic determinants, can be destroyed by radiation cross-fire. Radioimmunotherapy is sometimes called targeted radiotherapy, but this latter term can also refer to radionuclides linked to non-immune molecules (see RADIOTHERAPY).

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