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Clinical Trials/NCT02510378
NCT02510378UnknownPhase 2

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

Chinese Academy of Medical Sciences3 sites in 1 country47 target enrollmentStarted: January 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
47
Locations
3
Primary Endpoint
percentage of patients undergo R0 surgery during the follow-up
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hua Ren

Attending physician

Chinese Academy of Medical Sciences

Study Sites (3)

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Short Course Radiotherapy Combined With... | Clinical Trial