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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3506 - Short-Term radiotherapy plus chEmotherapy versus Long-term chemoradiotherapy in Locally Advanced Rectal cancer (STELLAR): a planned interim analysis

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy;  Radiation Oncology

Tumour Site

Colon and Rectal Cancer

Presenters

Jing Jin

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

J. Jin1, Y. Tang1, S. Liu2, Y. Zhu3, W. Wang4, G. Li5, X. Wang6, J. Wang7, J. Yang8, S. Li9, N. Li9, W. Liu9, Y. Li9, Y. Chi10, A. Zhou11, J. Huang12, X. Wang13, L. Jiang14, J. Jiang14, S. Zou15

Author affiliations

  • 1 Radiation oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, 100021 - Beijing/CN
  • 2 Radiation oncology, Jilin Provincial Cancer Hospital, Changchun/CN
  • 3 Radiation oncology, Zhejiang Provincial Cancer Hospital, Hangzhou/CN
  • 4 Radiation oncology, Guizhou Provincial Cancer Hospital, Guiyang/CN
  • 5 Radiation oncology, Beijing Hospital, Beijing/CN
  • 6 Radiation oncology, West China Hospital, Sichuan University, Chengdu/CN
  • 7 Radiation oncology, Hebei Provincial Cancer Hospital, Shijiazhuang/CN
  • 8 Radiation oncology, Sichuang Provincial Cancer Hospital, Chengdu/CN
  • 9 Radiation oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing/CN
  • 10 Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, 100021 - Beijing/CN
  • 11 Department Of Medical Oncology, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 12 Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing/CN
  • 13 Colorectal Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing/CN
  • 14 Radiology Department, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing/CN
  • 15 Pathology Department, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing/CN
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Resources

Abstract 3506

Background

At present, distant metastasis remains the main cause of failure for locally advanced rectal cancer (LARC), efficient short-course radiotherapy (SCRT) combined with neoadjuvant chemotherapy is an attempt of optimizing pre-operative treatment.

Methods

We did this randomized, phase III study in multiple centers in China. Patients with middle or lower rectal adenocarcinomas, staged cT3-4 and/or N1-2 by MRI, were randomly assigned to receive 5Gy × 5 and 4 courses of CAPOX (experimental group) or 50 Gy in 25 fractions concurrently with capecitabine (control group). TME in both groups was performed 6-8 weeks later, then two or six courses of CAPOX as postoperative chemotherapy was prescribed in experimental or control group, respectively. The purpose of this interim analysis was focusing on the compararison of primary enrolled 100 patients.

Results

Initially enrolled 100 patients, 51 in experimental group and 49 in control group were analyzed, with MRF+ 27.5% vs. 30.6%, MRI based T3-4 92.2% vs. 98.0%, N1-2 74.5% vs. 77.6%, and EMVI scores3-4 52.9% vs. 65.3% in each group. The completion rates of neoadjuvant treatment were 98.0% vs. 100% (p = 0.325), with incidences of grade III-IV toxicity 17.6% vs. 4.1% (p = 0.076) in each group, respectively. 80 patients completed surgery and 7 patients (all in experimental group) chose “watch-and-wait” policy due to clinical complete remission (cCR) after neoadjuvant treatment. 92.9% and 89.5% of patients in experimental and control group had R0 resection (p = 0.593), while 26.2% and 5.3% of them achieved ypT0N0 (p = 0.011), respectively. The completion rates of adjuvant chemotherapy were 76.2% vs. 65.8% (p = 0.305) in each group, respectively. On the whole, the patients who had received 6 cycles of chemotherapy accounted for 62.7% vs. 49.0% (p = 0.000) in experimental and control group, and there were 76.5% and 49.0% of patients who could complete all planned treatments in each group, respectively.

Conclusions

The interim analysis revealed the acute toxicity and surgical complication were acceptable and comparable in both groups, however, the people in experimental group showed better treatment completion.

Clinical trial identification

NCT02533271.

Legal entity responsible for the study

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College.

Funding

Collaborative Innovation Center for Cancer Medicine [No. XT2015-03].

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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