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

• 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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-29
• Last Update Posted: 2015-07-29
• Primary Completion: 2020-12
• Study Completion: 2022-12

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

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