A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III)

A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III) - OITA-trial III

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012857

Enrollment

Registered

2014-01-15

Start date

2013-12-12

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

Interventions

S-1: 80 mg/m2 p.o. (day1-5, 8-12, 22-26, and 29-33) Radiation : Total 45Gy/25fr, 1.8Gy/day, on days 1-5, 8-12, 15-19, 22-26, and 29-33).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed rectal cancer (Ra, Rb, P) 2) Histologically confirmed adenocarcinoma 3) Within 28 days before registration, Clinical stage T3-4, N0-2(UICC 7th edition) 4) Age of 20 to 80 years old 5) PS(ECOG) 0-1 6) Previously untreated rectal cancer (including chemotherapy, radiotherapy, hormonal therapy, or surgery) 7) be able to take oral drugs 8) Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,< 12000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST,ALT <= 100U/L Cre <1.5mg/dl Ccr >= 60mL/min 9) Appropriate for the study at the physician's assessment 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of serious drug hypersensitivity or a history of drug allergy 2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less) 3) Patients with contraindication to S-1 4) Serious complication ( ex. intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, serious diabetes, serious hypertension cardiac failure, renal failure, or liver failure) 5) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema ) 6) Pleural effusion, peritoneal fluid that needs treatment 7) Positive for HBs antigen 8) Patients who have bleeding from GI tract, intestinal paralysis, intestinal obstruction, peptic ulcer 9) Patients who need flucytosine, phenytoin or warfarin potassium. 10) Requiring consecutive systemic administration of steroid drug 11) Pregnant or lactating woman 12) Man who hope for Partner's pregnant 13) High-grade stricture 14) Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
predictive value of pathological response	—

Secondary

Measure	Time frame
DFS, OS, Response rate, pathological response, Safety	—

Countries

Japan

Contacts

Public ContactMasafumi INOMATA

Oita University faculty of medicine Department of Gastroenterological and Pediatric Surgery

geka1@oita-u.ac.jp097-586-5843

Outcome results

None listed

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