Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

Stage IV Rectal Cancer, Liver Metastasis, Resectable Clinical Trial

Official title:

Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510378
• Other study ID #: CH-GI-072
• Status: Recruiting
• Phase: Phase 2
• First received: July 12, 2015
• Last updated: July 27, 2015
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: July 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Hua Ren
• Phone: 8610-87788122
• Email: renhua2009[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasm Metastasis
• Rectal Neoplasms
• Stage IV Rectal Cancer, Liver Metastasis, Resectable

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
China	Cancer Hospital, CAMS	Beijing
China	Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients undergo R0 surgery during the follow-up		3 months	No
Secondary	The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)		3 months	Yes