Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
Phase 2
- Conditions
- Stage IV Rectal Cancer, Liver Metastasis, Resectable
- Interventions
- Radiation: Short course radiotherapy
- Registration Number
- NCT02510378
- Lead Sponsor
- Chinese Academy of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 47
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Short course radiotherapy Short course radiotherapy 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.
- Primary Outcome Measures
Name Time Method percentage of patients undergo R0 surgery during the follow-up 3 months
- Secondary Outcome Measures
Name Time Method The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0) 3 months
Trial Locations
- Locations (2)
Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
🇨🇳Beijing, Beijing, China
Cancer Hospital, CAMS
🇨🇳Beijing, China