Radiotherapy quality assurance in clinical trials. 1984

C A Perez, and P Gardner, and G P Glasgow

The goal of radiation therapy is to yield the greatest possible uncomplicated local and regional tumor control. An acceptable quality of life with few severe complications, anatomical defects or psychological disturbances should be an integral objective of excellent radiation therapy. Inasmuch as higher doses of irradiation and adequacy of treatment portals (volume irradiated) appear to correlate with greater probability of tumor control and major complications, there is a critical need to optimize treatment planning and quality assurance in radiation therapy. Along with this, techniques must be developed for reliable patient reposition and immobilization so that the optimized treatment plan can be translated into precise delivery of the irradiation. It is obvious that in clinical trials the basic parameters of therapy need to be optimally observed, in order to make comparison of experimental arms more reliable. It is easier to achieve uniformity of technical factors in a study at a single institution than in multi-institutional cooperative groups. Thus, stringent criteria must be incorporated into the protocol describing the requirements and techniques for planning and delivery of the radiation therapy. Furthermore, the dosimetry checks carried out by the Radiological Physics Center should be an integral part of this program. In some studies it is necessary to do an initial review of dosimetry factors and portal films. This alerts the radiation oncologist to variations from the protocol and, with prompt feedback and correction of the potential error, will ensure the complete evaluability of the case. Since an increasing number of reports point out that the doses of irradiation delivered and the volume treated may affect therapeutic results, a completed case review should always be carried out. Some cooperative group studies strongly suggest a correlation between the compliance with the protocol and the results of the trial. Costs of these programs in clinical trials should be justified since, for a small investment, the evaluability rate in a protocol can be increased by 10%. The increase of patient evaluability significantly decreases the cost per evaluable patient. Furthermore, the reliability of the data of the trial will be greatly enhanced by a strong quality assurance program.

UI MeSH Term Description Entries
D008175 Lung Neoplasms Tumors or cancer of the LUNG. Cancer of Lung,Lung Cancer,Pulmonary Cancer,Pulmonary Neoplasms,Cancer of the Lung,Neoplasms, Lung,Neoplasms, Pulmonary,Cancer, Lung,Cancer, Pulmonary,Cancers, Lung,Cancers, Pulmonary,Lung Cancers,Lung Neoplasm,Neoplasm, Lung,Neoplasm, Pulmonary,Pulmonary Cancers,Pulmonary Neoplasm
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D011785 Quality Assurance, Health Care Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps. Quality Assessment, Health Care,Health Care Quality Assessment,Health Care Quality Assurance,Healthcare Quality Assessment,Healthcare Quality Assurance,Quality Assessment, Healthcare,Quality Assurance, Healthcare,Assessment, Healthcare Quality,Assessments, Healthcare Quality,Assurance, Healthcare Quality,Assurances, Healthcare Quality,Healthcare Quality Assessments,Healthcare Quality Assurances,Quality Assessments, Healthcare,Quality Assurances, Healthcare
D011878 Radiotherapy The use of IONIZING RADIATION to treat malignant NEOPLASMS and some benign conditions. Radiotherapy, Targeted,Targeted Radiotherapy,Radiation Therapy,Radiation Therapy, Targeted,Radiation Treatment,Targeted Radiation Therapy,Radiation Therapies,Radiation Therapies, Targeted,Radiation Treatments,Radiotherapies,Radiotherapies, Targeted,Targeted Radiation Therapies,Targeted Radiotherapies,Therapies, Radiation,Therapies, Targeted Radiation,Therapy, Radiation,Therapy, Targeted Radiation,Treatment, Radiation
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003365 Costs and Cost Analysis Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs. Affordability,Analysis, Cost,Cost,Cost Analysis,Cost Comparison,Cost Measures,Cost-Minimization Analysis,Costs and Cost Analyses,Costs, Cost Analysis,Pricing,Affordabilities,Analyses, Cost,Analyses, Cost-Minimization,Analysis, Cost-Minimization,Comparison, Cost,Comparisons, Cost,Cost Analyses,Cost Comparisons,Cost Measure,Cost Minimization Analysis,Cost, Cost Analysis,Cost-Minimization Analyses,Costs,Measure, Cost,Measures, Cost
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.

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