According to the 2013 National Comprehensive Cancer Network guidelines, pelvic concurrent chemoradiation therapy (CRT) is one of the preferred regimens for patients with metastatic rectal cancer (mRC). Patients with stage IV rectal or rectosigmoid cancer were identified in the SEER database (2004-2009). Treatment regimens (with or without surgical resection, with or without RT) were recorded, 5-year survival rates of stage IV rectal cancer differed between treatment groups, with the highest survival rates observed among those who received combined surgery and RT. Furthermore, according to the 2013 ESMO guidelines, short course radiotherapy combined with chemotherapy maybe a modality more suitable to stage IV rectal cancer. Therefore, we plan to evaluate the efficacy and safety of short course radiotherapy in stage IV rectal cancer with resectable liver metastases.
Forty-seven patients of stage IV rectal cancer with resectable liver metastasis will be enrolled in cancer hospital, CAMS. This open-label, single-arm phase II clinical study was approved by the ethical committee and registered on clinicaltrial.gov (NCT02510378). All patients provided written informed consent. The primary end point is the percentage of patients receiving radical surgical treatment of all tumor sites (R0). Secondary end points are 2-year survival, 2-year recurrence rate, and treatment-related toxicity.
Preoperative pelvic radiotherapy (25 Gy/ 5 f/ 5 days) will be delivered with IMRT. The clinical target volume include the rectal tumor, mesorectum, and internal iliac lymph nodes. Systemic therapy was started within 2 weeks of completing radiotherapy. Patients will be treated with at least four cycles of CapeOx unless unacceptable toxicity occur.After completing preoperative treament, patients will be reassessed for resectability by clinical examination, CT, MRI and optionally PET/CT. Decision for surgery will be made in cancer hospital by a multidisciplinary team.
Clinical trial identification
All authors have declared no conflicts of interest.