The purpose of this paper is to review the primary data of the clinical tri
als performed by the Radiation Therapy Oncology Group (RTOG) for patients w
ith carcinoma of the uterine cervix. The trials, their strengths, limitatio
ns, and the implications of the results are discussed.
During the past 25 years there have been several clinical trials performed
by the RTOG to test various hypotheses for improving local control and surv
ival for patients with carcinoma of the uterine cervix. The major research
themes that have been appraised are the use of hyperbaric oxygen, altered f
ractionation radiotherapy, hypoxic cell sensitization, chemo-sensitization,
prophylactic paraaortic irradiation, and neutron radiotherapy. There are t
wo general research themes. The initial RTOG trials for cervical cancer att
empted to address the issues of tumor volume and hypoxic cells while the la
tter studies addressed these issues and the issue of micrometastatic diseas
e.
The phase III clinical trials performed by the RTOG have not demonstrated a
local control or survival advantage in the experimental arm with the use o
f hyperbaric oxygen, split-course radiotherapy, hypoxic cell sensitization,
or neutron radiotherapy. Acceptable toxicity and efficacy results were sho
wn in phase II studies evaluating twice-daily irradiation and chemo-sensiti
zation. The positive phase III trials were RTOG 79-20 which evaluated proph
ylactic paraaortic irradiation in patients with bulky stages IB, IIA, and I
IB disease, and RTOG 90-01 which evaluated concurrent chemotherapy. Results
of more recent clinical trials are pending their completion.