Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 47
- Locations
- 3
- Primary Endpoint
- percentage of patients undergo R0 surgery during the follow-up
Study Overview
Brief Summary
Patients with rectal cancer and resectable liver metastases receive short course radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles after 2 weeks.
Detailed Description
Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.
After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings.
Exclusion Criteria
- •Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
Outcomes
Primary Outcomes
percentage of patients undergo R0 surgery during the follow-up
Time Frame: 3 months
Secondary Outcomes
- The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)(3 months)
Investigators
Hua Ren
Attending physician
Chinese Academy of Medical Sciences
