Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer. Clinical significance of additional systemic chemotherapy before surgery.

Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer. Clinical significance of additional systemic chemotherapy before surgery. - Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013494

Enrollment

Registered

2014-03-24

Start date

2013-10-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Stage II /Stage III rectal cancer

Interventions

Standard therapy group 1 (4 weeks of S-1) Trial therapy group 1 (8 weeks of S-1) Standard therapy group 2 (5 weeks of UFT/LV) Trial therapy group 2 (10 weeks of UFT/LV)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: clinical Stage II/III rectal cancer

Exclusion criteria

Exclusion criteria: emergency surgery

Design outcomes

Primary

Measure	Time frame
rate of pCR (pathological complete regression)	—

Secondary

Measure	Time frame
Tumor regression grading, rate of R0 resection, rate of daownstaging, Disease-free survival, Overall survival	—

Countries

Japan

Contacts

Public ContactSotaro Sadahiro

Tokai University Gastrointestinal Surgery

sadahiro@is.icc.u-tokai.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026