Download Gastrointestinal tumours - Oxford Academic

Annals of Oncology 26 (Supplement 9): ix42–ix70, 2015
doi:10.1093/annonc/mdv523.96
Gastrointestinal tumours
235TiP
Phase III study of short-term radiotherapy followed by
neoadjuvant chemotherapy versus preoperative long-term
chemoradiotherapy in locally advanced rectal cancer
Y. Tang, J. Jin, N. Ling, H. Ren, W-H. Wang, Y-W. Song, Y-P. Liu, S-L. Wang,
H. Fang, Y-X. Li
Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical
Sciences (CAMS), Beijing, China
abstracts
Background: Phase III study of short-term radiotherapy followed by neoadjuvant
chemotherapy versus preoperative long-term chemoradiotherapy in locally advanced
rectal cancer (STELLAR trial) How to optimize preoperative treatment regimens for
locally advanced rectal cancer (LARC) is the focus of recent studies, The purpose of
STELLAR trial is to compare short course radiotherapy (SCRT) followed by
neoadjuvant chemotherapy (NACT) with preoperative chemoradiotherapy (CRT) in
patients with LARC.
Trial design: The purpose of the STELLAR trial is to compare effectiveness of short
course radiotherapy (SCRT) followed by neoadjuvant chemotherapy (NACT)
(experimental group) with preoperative long-term chemoradiotherapy (CRT) (control
group) in locally advanced rectal cancer (LARC). The hypothesis is 3-year disease-free
survival in experimental group was non-inferior to that in control group. STELLAR
trial is an open-label, prospective phase III randomized trial. At least five hundred and
fifty-two previously untreated patients of stage II/III rectal adenocarcinoma between
the age of 18 and 70 will be enrolled and randomized into experimental group or
control group. All patients will be provided with written informed consents and cancer
staging must be based on pelvic MRI. The primary endpoint is 3-year disease-free
survival. In experimental group, patients will receive a SCRT (25 Gy/ 5 fractions/
5 days), followed by NACTs after 7-10 days of radiotherapy, given in three-week-cycle
of capecitabine 1000 mg/m2 twice daily, day 1–14 combined with oxaliplatin
130 mg/m2 day 1. In total, 4 cycles of NACTs are prescribed preoperatively, followed
by a TME surgery and postoperative adjuvant chemotherapy. In control group, patients
will receive a long-term CRT (50Gy/ 25 fractions/35 days with capecitabine)
preoperatively, followed by a TME surgery and then postoperative adjuvant
chemotherapy. Capecitabine is given in combination with radiation at a dose of 825
mg/m2 twice daily on radiotherapy days, excluding weekends.
Clinical trial identification: NCT02533271
Disclosure: All authors have declared no conflicts of interest.
© European Society for Medical Oncology 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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