235TiP - Phase III study of short-term radiotherapy followed by neoadjuvant chemotherapy versus preoperative long-term chemoradiotherapy in locally advanced...

Date 19 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 1
Topics Cytotoxic agents
Surgical oncology
Colon and Rectal Cancer
Therapy
Biological therapy
Radiation oncology
Presenter Yuan Tang
Citation Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523
Authors Y. Tang
  • Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS), 100021 - Beijing/CN

Abstract

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.