Recurrent Rectal Cancer Clinical Trial
Official title:
Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer
Treatment standard for patients with rectal cancer depends on the initial staging and
includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III
tumors, radiochemotherapy should be performed in addition to surgery, preferentially as
preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in
surgical approaches, especially the establishment of the total mesorectal excision (TME) in
combination with sophisticated radiation and chemotherapy have reduced local recurrence rates
to only few percent. However, due to the high incidence of rectal cancer, still a high
absolute number of patients present with recurrent rectal carcinomas, and effective treatment
is therefore needed.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile
and the high local dose deposition within the Bragg peak precise dose application and sparing
of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an
increase relative biological effectiveness (RBE), which can be calculated between 2 and 5
depending on the cell line as well as the endpoint analyzed.
Japanese data on the treatment of patients with recurrent rectal cancer previously not
treated with radiation therapy have shown local control rates of carbon ion treatment
superior to those of surgery. Therefore, this treatment concept should also be evaluated for
recurrences after radiotherapy, when dose application using conventional photons is limited.
Moreover, these patients are likely to benefit from the enhanced biological efficacy of
carbon ions.
In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy
for recurrent rectal cancer will be determined in the Phase I part, and feasibility and
progression-free survival will be assessed in the Phase II part of the study.
Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.
The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II
part its progression-free survival.
n/a
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