ISRCTN11812525
Completed
Phase 2
A phase II study of preoperative chemoradiation with UFT-E plus leucovorin and the translational research for detection of predictive markers in the patients with locally advanced resectable rectal cancer
ational Cancer Center0 sites121 target enrollmentJuly 25, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ocally advanced rectal cancer (cT3-4, Nx, M0)
- Sponsor
- ational Cancer Center
- Enrollment
- 121
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically diagnosed adenocarcinoma of rectum
- •2\. Located within 8cm from anal verge
- •3\. cT3/4 by rectal MRI\+/\- endorectal ultrasound
- •4\. 18 years old or more
- •5\. ECOG performance status \<\=2
- •6\. No previous chemotherapy
- •7\. No previous radiotherapy to pelvis
- •8\. Adequate bone marrow, hepatic, and renal function
Exclusion Criteria
- •1\. Rectal cancer of histology other than adenocarcinoma
- •2\. Adenocarcinoma developed from inflammatory bowel disease
- •3\. Presence of distant metastases
- •4\. Existence of unresected synchronous colon cancer
- •5\. Unresolved bowel obstruction
- •6\. Clinically unresectable disease
- •7\. Uncontrolled cardiovascular disease
- •8\. Uncontrolled active infection
- •9\. History of other malignancies within 5 years from screening
- •10\. History of organ transplantation that necessitates immunosuppressive treatment
Outcomes
Primary Outcomes
Not specified
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