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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11812525

Enrollment

121

Registered

2016-07-25

Start date

2009-01-09

Completion date

Unknown

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced rectal cancer (cT3-4, Nx, M0) Cancer

Interventions

This is a single-arm, phase II study of preoperative radiotherapy (RT) with enteric-coated tegafur-uracil (UFT-E) and leucovorin. 1. Radiotherapy (RT): started within 14 days after screening and obta

BSA 1.63 m2 – 1.87 m2: 3, 2, and 2 packages 2.3. BSA ³ 1.88 m2: 3, 3, and 2 packages 3. Leucovorin: 30mg (2 tablets) p.o. With each UFF-E dose, corresponding to a total daily dose of 90 mg 4. Surgery:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Pathologic complete response by Dworak’s classification, assessed with surgical specimen (including primary tumor and regional lymph nodes) derived from total mesorectal excision. Dworak’s classification: Grade 0 no regression Grade 1 dominant tumor mass with obvious fibrosis and/or vasculopathy Grade 2 dominantly fibrotic changes with few tumor cells or groups (easy to find) Grade 3 very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance Grade 4 no tumor cells, only fibrotic mass (total regression or response)	—

Measure

Time frame

Pathologic complete response by Dworak’s classification, assessed with surgical specimen (including primary tumor and regional lymph nodes) derived from total mesorectal excision. Dworak’s classification: Grade 0 no regression Grade 1 dominant tumor mass with obvious fibrosis and/or vasculopathy Grade 2 dominantly fibrotic changes with few tumor cells or groups (easy to find) Grade 3 very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance Grade 4 no tumor cells, only fibrotic mass (total regression or response)

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Secondary

Measure	Time frame
1. Safety: measured with National Cancer Institute Common Terminology Criteria (NCI-CTC) scale, version 3.0 2. Relapse-free survival : the time from the date of starting CRT to the date on which either of recurrence, progression, or death was first observed, or the date of last follow-up 3. Overall survival: the time from the date of starting CRT to the date of death from any cause or last follow-up 4. Pharmacogenetic analysis: genomic DNA from peripheral blood will be analyzed for the following polymorphism: CYP2A64 (whole deletion of CYP2A6), CYP2A67 (6558T>G, rs5031016), CYP2A69 (-48T>G, rs28399433), CYP2A610 (6558T>C and 6600G>T, rs28399468), UMPS 638G>C (rs1801019), ABCB1 3545 C>T (rs1045642), ABCB1 1236 C>T (rs1128503), and ABCB1 2677 G>T/A (rs2032582)	—

Measure

Time frame

1. Safety: measured with National Cancer Institute Common Terminology Criteria (NCI-CTC) scale, version 3.0 2. Relapse-free survival : the time from the date of starting CRT to the date on which either of recurrence, progression, or death was first observed, or the date of last follow-up 3. Overall survival: the time from the date of starting CRT to the date of death from any cause or last follow-up 4. Pharmacogenetic analysis: genomic DNA from peripheral blood will be analyzed for the following polymorphism: CYP2A6*4 (whole deletion of CYP2A6), CYP2A6*7 (6558T>G, rs5031016), CYP2A6*9 (-48T>G, rs28399433), CYP2A6*10 (6558T>C and 6600G>T, rs28399468), UMPS 638G>C (rs1801019), ABCB1 3545 C>T (rs1045642), ABCB1 1236 C>T (rs1128503), and ABCB1 2677 G>T/A (rs2032582)

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Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026