Preoperative chemoradiation with UFT-E plue leucovorin and translational study for locally advanced rectal cancer

Phase 2

Completed

• Conditions: ocally advanced rectal cancer (cT3-4, Nx, M0); Cancer

• Registration Number: ISRCTN11812525
• Lead Sponsor: ational Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-25
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 121

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
11. Uncontrolled epileptic disease or psychiatric disease
12. Pregnant or breastfeeding women, or women with child-bearing potential who are not compliant to 13. Contraception policy of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified