National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
February 23, 2010 • Volume 7 / Number 4

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Guest Director's Update

Working within Radiation Oncology to Maximize Benefits and Minimize Harms

Dr. Bhadrasain Vikram, Dr. James Deye, and Dr. C. Norman Coleman From left to right: Dr. Bhadrasain Vikram, Dr. James Deye, and Dr. C. Norman Coleman

Radiation therapy has been used to treat cancer for over a century. A high enough dose of ionizing radiation will kill any living cell, and cancer cells are no exception. The objective of radiation therapy, therefore, is to deliver high enough doses of radiation to cancer cells while minimizing the dose to healthy cells that are also exposed. 

We are not yet at a point where we can image individual cancer cells in cancer patients, but we can image macroscopic clusters of cancer cells ranging in size from a few millimeters to several centimeters. The radiation oncologist then strives to irradiate that cluster of cancer cells (the “target volume”) in a beam of high-dose radiation while minimizing the dose to healthy tissues (the “organs at risk”) outside the cluster. Invariably, due to the intertwining of tumor cells and normal tissues both at the margins but also within the center of the tumor, there is some radiation delivered to the organs at risk. This can lead to adverse effects, ranging from those appearing within hours or days (diarrhea during irradiation of a cancer located in the abdomen or pelvis, for instance) to those appearing decades later, such as tissue scarring and radiation-induced second cancers.

The radiation device industry has worked with researchers in the field to make it easier for radiation oncologists to “conform” the high-dose region to the target volume by introducing new technologies such as three-dimensional conformal radiation therapy, intensity-modulated radiation therapy, stereotactic radiation therapy, and proton radiation therapy. Several new devices have received 510(k) Clearances by the FDA on the basis that they are extensions of existing technology, and these devices are now used in routine clinical practice by radiation oncologists and reimbursed by insurers. However, as pointed out in a series of recent articles in The New York Times, the complexity of the new technology and the rapid pace at which it has entered practice may have created new avenues for error.
 
NCI is a research institution. Thus, it does not regulate technology or reimbursement. But given the importance of quality assurance for the conduct of NCI clinical trials, and recognizing radiation technology’s promise as well as potential pitfalls, more than 10 years ago the Radiation Research Program (RRP) and the Cancer Therapy Evaluation Program in NCI’s Division of Cancer Treatment and Diagnosis set about establishing an agile and continuously evolving infrastructure to: 1) protect patients volunteering in multi-institutional clinical trials sponsored by NCI who would receive advanced-technology radiation therapy as a part of their treatment; and 2) facilitate robust clinical trials to evaluate the benefits and harms of the new technology.

As a result, NCI not only supports research to develop and evaluate new radiation technology, we also support numerous clinical trials where the principal question is not specifically related to the radiation but the quality of radiation must be appropriately safeguarded so that it does not jeopardize the ability of the trial to test its hypothesis.

NCI’s contribution to quality cancer care extends well beyond the 1 to 2 percent of the patients receiving radiation therapy in the United States as a part of an NCI-sponsored clinical trial. As noted in The New York Times series, our policies, procedures, and lessons learned have in some cases been adopted or adapted by other institutions and organizations interested in improving quality and protecting patients. These include credentialing of individuals and facilities, quality monitoring and mentoring, training tools, and analyses of patient outcomes. Additional information about the NCI-supported infrastructure can be obtained from the RRP and the following links:

  1. The NCI Advanced Technology Consortium and the Radiological Physics Center
  2. The Current Status and Future Potential of Advanced Technologies in Radiation Oncology: Part 1, Part 2, Commentary 1, Commentary 2

Looking to the future, the infrastructure created by NCI can serve as an important resource—perhaps even the foundation—for quality improvement programs envisioned by other federal and state agencies, professional societies, institutions, and individuals. We are working closely with our colleagues in the cancer Biomedical Informatics Grid (caBIG) to make that possible, as well as with colleagues at the FDA, Veterans Health Administration, Agency for Healthcare Research and Quality, and professional organizations such as the American Association of Physicists in Medicine and American Society for Therapeutic Radiology and Oncology. Already, approximately 20 percent of radiation oncology facilities in the United States are capable of digital data exchange through this infrastructure.

Furthermore, thanks to the harmonization efforts of the last decade and outreach to industry, it is possible to link most of the remaining facilities to this infrastructure for digital data transfer, collection, and analyses. Therefore, although this NCI infrastructure was created to facilitate multi-institutional prospective treatment efficacy trials, it could also facilitate other kinds of studies, including observational or cohort studies for comparative effectiveness research and post-marketing surveillance of new drugs and devices.

Finally, it could also serve as a demonstration project for a “learning health care system,” wherein each new patient will be precisely matched to similar patients in the vast national and even global database to help physicians select the best personalized treatment strategy that will result in the best possible outcome for their patients.

Dr. Bhadrasain Vikram
Branch Chief and Deputy Associate Director
Radiation Research Program, NCI Division of Cancer Treatment and Diagnosis


Dr. James Deye
Program Director

Radiation Research Program, NCI Division of Cancer Treatment and Diagnosis

Dr. C. Norman Coleman
Associate Director
Radiation Research Program, NCI Division of Cancer Treatment and Diagnosis

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