© 1998 by Oxford University Press
A new cooperative trial group will fill a need to assess emerging techniques and technologies in oncologic surgery, say officials at the National Cancer Institute and the American College of Surgeons where the group is headquartered. By involving ACOS's large membership, the group may be able to complete its trials quickly, they say, in sync with the often rapid deployment of new surgical procedures.
The American College of Surgery Oncology Group or ACoSOG, will launch its first collaborative, multicenter trials in the next few months, according to Samuel A. Wells, M.D., group chair and the new director of the American College of Surgeons, which is based in Chicago. Wells and NCI director Richard Klausner, M.D., announced the formation of the new, NCI-sponsored group last month at the annual meeting of the Society of Surgical Oncology in San Diego.
Some other cooperative trial groups and some grant-supported investigators conduct surgical trials, but not in great numbers. A recent search of PDQ, NCI's clinical trials database, turned up 160 active surgery protocols compared to 1,223 for chemotherapy and 728 for radiation therapy. The involvement of the American College of Surgeons will permit more phase III trials to be performed and allow these trials to be performed more quickly," said Edward Trimble, M.D., head of the Surgery Section in NCI's Clinical Investigations Branch.
Surgeons say quickness is especially important in a field where new technologies and procedures may spread rapidly before there are definitive data on their benefits. "With emerging technologies, we need to implement trials quickly," said Valerie Rusch, M.D., a thoracic surgeon at Memorial Sloan Kettering Cancer Center in New York. "Otherwise they quickly become standard-of-care before anybody really knows anything about them."
She pointed out that when computerized tomography became available, it took over 10 years of small studies to determine its role in managing cancer.
Rusch is leading several of ACoSOG's first trials, including two that will assess whether positron emission tomography can replace other tests, such as computerized tomography and magnetic resonance imaging, in staging esophageal and non-small-cell lung cancer. She said that the large multicenter trials, each involving several hundred patients, will make it possible to settle the question in 2 or 3 years.
Another trial will assess sentinel node biopsy in early breast cancer, a technique in which surgeons remove and obtain a biopsy specimen from only one or two underarm lymph nodes instead of performing a complete axillary dissection. This innovation is rapidly becoming popular with both patients and surgeons because it avoids the lymphedema that plagues many breast cancer survivors.
But major questions remain, including whether early breast cancer patients can safely forego complete axillary dissection in favor of sentinel lymph node biopsy. Investigators hope that the ACoSOG randomized trial will provide some answers before the new technique becomes standard-of-care. This study will be led by Armando Giuliano, M.D., John Wayne Cancer Center, Santa Monica, Calif., and Douglas Reintgen, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla.
With its base in a professional group, ACoSOG is unique among the NCI-sponsored cooperative trial groups. Most surgeons in the United States and Canada belong to the 62,000-member organization, Wells said, providing a large potential pool of participants. Surgeons from both academic settings and community hospitals are expected to participate.
ACoSOG will also have institutional members, Wells said, although details of the structural framework are still being worked out. He said that the designs for the first nine trials are now undergoing review and that he hopes some trials will get under way in late spring or early summer.
In addition to the sentinel lymph node and PET scan studies, the first ACoSOG trials will include a comparison of mediastinal lymph node sampling versus compete lymphadectomy in patients with early stage lung cancer. Other trials will address colorectal cancer, melanoma, and retinoblastoma.
More trials are in the design stage, and these will address surgical issues in cancers of the pancreas, rectum, and prostate, Trimble said.
-- Caroline McNeil
New Cooperative Trial Group Will Focus on Oncologic Surgery
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