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Preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013486
Enrollment
50
Registered
2014-03-24
Start date
2014-02-26
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) Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)

Sponsors

National Defense Medical College
Lead Sponsor
Self-Defense Forces Central Hospital
Collaborator

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

MeasureTime frame
pathological Complete Response rate Predictive value for tumor regression

Secondary

MeasureTime 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