Clinical trial of preoperative chemoradiotherapy with TS-1 for locally advanced lower rectal cancer

Clinical trial of preoperative chemoradiotherapy with TS-1 for locally advanced lower rectal cancer - preoperative chemoradiotherapy with TS-1 for rectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004762

Enrollment

Registered

2010-12-21

Start date

2010-12-01

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 lower rectal cancer

Interventions

preoperative TS-1 treatment, preopeorative radiation, operation, postoperative TS-1 treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) pathologically diagnosed as rectal adenocarcinoma (2)located in lower rectum (3)preoperative diagnosis; T3-T4 or T2N1-2 (4)no metastatic lesion (5)ECOG performance status; 0-1 (6)age between 20-80 (7)no previous treatment for rectal cancer (8)normal vital organ condition (9)oral administration is available (10)informed consent

Exclusion criteria

Exclusion criteria: (1)drug allergy (2)active multi cancer (3)contraindication of TS-1 (4)major complication (5)interstitial pneumonia (6)pleural effusion or ascites (7)fresh gastrointestinal bleeding (8)positive HBs antigen (9)treating docter judged incompatible

Design outcomes

Primary

Measure	Time frame
3 year disease free survival rate	—

Secondary

Measure	Time frame
local recurrence rate, pathological effectiveness, down staging rate, anal preserving rate, total survival period, safety, treatment completing rate	—

Countries

Japan

Contacts

Public ContactSoichiro Murata

University of Tsukuba, graduate school of comprehensive human sciences, clinical sciences Organ Transplantation Gastroenterological and Hepatobiliary Surgery

soichiro@md.tsukuba.ac.jp029-853-3221

Outcome results

None listed

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