A University of Michigan physician is one of five early career doctors selected to take part in the Southwest Oncology Group Young Investigator Training Course for 2009.
Reshma Jagsi, M.D., Ph.D., assistant professor of radiation oncology
at the U-M Medical School
, will attend a three-day workshop Sept. 15-17 in Seattle for intensive training in how to design and conduct cancer clinical trials.
The annual workshop is run by the Southwest Oncology Group (SWOG)
, one of the nation's largest cancer clinical trials networks, which is headquartered at the University of Michigan.
Jagsi and her four colleagues "are cancer researchers who have trained extensively in laboratory and clinical work," says Laurence H. Baker, D.O., SWOG group chair and professor of internal medicine
at the U-M Medical School. "This workshop will give them the tools to bring all of that together to design, implement and manage an effective clinical trial that may involve hundreds of patients at dozens of institutions throughout North America."
Experienced clinical investigators, statisticians and research ccoordinators from the National Cancer Institute
-supported Southwest Oncology Group will work with the Young Investigators, providing training in statistical principles, data collection and analysis, and critical decision-making. Many of the trials developed in previous workshops have since been launched as phase II or phase III studies with NCI funding.
As part of her application for the program, Jagsi has proposed a prospective observational study looking at the outcomes of breast reconstruction in patients who receive post-mastectomy radiation therapy.
"Federal law now mandates insurer coverage of breast reconstructive surgery, and with radiation now an established component of cancer care in a substantial proportion of mastectomy patients, the number of patients undergoing both treatments is likely to increase," Jagsi says. "Yet little high-quality evidence exists regarding the optimal sequencing of these treatments, with some women offered immediate reconstruction at the time of mastectomy and others counseled to wait until after radiation is complete."
Her study will gather data on patient satisfaction with cosmetic outcomes and decision-making, as well as complication rates, among patients undergoing immediate versus delayed reconstruction procedures.
The other four 2009 SWOG Young Investigators are as follows:
Neeraj Agarwal, M.D., Huntsman Cancer Institute, University of Utah:
Agarwal proposed a phase II clinical trial to test the agent cediranib, a pan-VEGF inhibitor, in treating patients with metastatic prostate cancer whose disease has progressed on first-line therapy with docetaxel. Agarwal's trial would compare patients receiving mitoxantrone either with or without cediranib with the goal of significantly improving progression free survival in this setting.
"My research experience has convinced me that only an integration of bench research with clinical research can lead to the design of truly original clinical trials that will lead to a better understanding of disease patho-physiology and treatment," says Agarwal. "Achieving an ideal mix of this remains my ultimate goal."
Eduardo Gharzouzi, M.D., Guatemalan Cancer Institute, Instituto de Cancerologia:
As an oncologist in a country where 80 percent of cancer patients are diagnosed when their disease is at an advanced stage, and in which almost all of those patients are without the resources to pay for a full course of cancer treatment, Gharzouzi has a longer-term goal of establishing a clinical research center at the Instituto de Cancerologia in his home country of Guatemala.
He has proposed a phase III trial testing the use of cetuximab to treat gastric cancer, one of the most common cancers in Latin America. The trial would compare outcomes in patients with advanced gastric cancer treated with a standard course of oxaliplatin, capecitabine, and radiotherapy either with or without cetuximab.
Gharzouzi writes that in addition to his interest in the new drugs, regimens, and modalities of treatment that grow from clinical trials, he is also excited about being able, as part of clinical trials, to offer his patients treatment they might otherwise never get.
Dipen J. Parekh, M.D., University of Texas Health Science Center San Antonio:
As director of robotic surgery in the Department of Urology at his institution, Parekh has proposed a trial to compare the effectiveness of robot-assisted surgery with open surgery in performing radical cystectomy for invasive bladder cancer.
"Routine use of robotic surgery can only be justified if it leads to significant benefits in improving patient recovery," says Parekh, "with superior or at least equal oncologic outcomes."
His pilot study would assess and compare functional recovery and independence rates of robotic surgery patients to those of open surgery patients. It would also give researchers important data to use in establishing statistical benchmarks that would inform the design of a larger, more definitive trial.
Brian Till, M.D., University of Washington and Fred Hutchinson Cancer Research Center:
Mantle cell lymphoma (MCL) carries perhaps the worst prognosis among all subtypes of non-Hodgkin lymphoma, with the majority of cases presenting at an advanced stage and considered incurable. Citing studies that show a synergistic effect of the drugs bendamustine and rituximab, Till has proposed a phase II trial to test the impact of these two drugs combined with bortezomib on the progression-free survival of patients with relapsed MCL.
"Mantle cell lymphoma, unlike some types of lymphoma that can be cured with chemotherapy alone, is difficult to treat," says Till. "New therapies are clearly needed, and this is a challenge that appeals to me as an investigator."
Costs of the Young Investigator program are paid for with a gift from the Hope Foundation
, a philanthropic arm of the Southwest Oncology Group that raises funds for educational and research efforts.
The Southwest Oncology Group
) is one of the largest cancer clinical trials cooperative groups in the United States. Funded primarily by the National Cancer Institute, the group designs and conducts clinical trials to advance the science of cancer prevention and treatment and to improve the quality of life for cancer survivors. The almost 5,000 physician-researchers in the Group's network practice at more than 500 institutions, including 19 of the National Cancer Institute-designated Comprehensive Cancer Centers. The Group is headquartered at the University of Michigan in Ann Arbor, Mich. (734-998-7140). The Group has an operations office in San Antonio, Texas and a statistical center in Seattle, Wash.