Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer

Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer - Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011993

Enrollment

100

Registered

2013-10-09

Start date

2011-05-01

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

Locally advanced rectal cancer Locally advanced anal cancer

Interventions

S-1(80mg/m2/day1-5,8-12,22-26,29-33) irinotecan(80mg/m2/day1,8,22,29) Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III. (2) Histologically confirmed adenocarcinoma (3) Without prior anti-tumor therapy (4) Age:20-80years old (5) Performance status 0-2 (6) Adequate organ function WBC>= 4,000 <= 15,000/mm3 neutro>= 2,000/mm3 Plt>= 100,000/mm3 Hb>= 8.0g/dl Cr<= 1.5mg/dl T-Bil<= 1.5mg/dl AST, ALT<= double of the upper limit (7) Written IC with date

Exclusion criteria

Exclusion criteria: Patients judged inappropriate for this study by the physicians

Design outcomes

Primary

Measure	Time frame
pathological Complete Response rate Predictive value for tumor regression	—

Secondary

Measure	Time frame
Relapse free survival (RFS) Overall survival (OS) Rate of local recurrence Safety	—

Countries

Japan

Contacts

Public ContactEiji Shinto

National Defense Medical College Surgery

eiji-c@zf6.so-net.ne.jp04-2995-1511

Outcome results

None listed

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