Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
1 other identifier
interventional
47
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2014
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 12, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 29, 2015
July 1, 2015
6.9 years
July 12, 2015
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of patients undergo R0 surgery during the follow-up
3 months
Secondary Outcomes (1)
The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)
3 months
Study Arms (1)
Short course radiotherapy
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Cancer Hospital, CAMS
Beijing, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
July 12, 2015
First Posted
July 29, 2015
Study Start
January 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2022
Last Updated
July 29, 2015
Record last verified: 2015-07