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Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer

Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer - Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013598
Enrollment
30
Registered
2014-04-01
Start date
2013-12-01
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

Low rectal cancer

Interventions

TS-1:80mg/m2-120mg/m2 day1-5,8-12,15-19,22-26,29-33 Radiation:1.8Gy of consecutive 5days, Total dose 45 Gy

Sponsors

Toho University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed low Rectum adenocarcinoma(without Rs) 2.Preoperative CT or MRI findings the clinical stage is T3-4 and any N 3.Recectable 4.No evidence of peritoneal metastasis, liver metastasis and distant metastasis. 5.age:20-80years old 6.Performance status 0-1 7.Without prior anti-tumor therapy 8. Adequate organ function 9.the case can eat 10.Written IC

Exclusion criteria

Exclusion criteria: 1.Impossible to receive TS-1 contained chemotherapy 2.Recieving the radiation therapy in a pelvis 3.Infection 4.Serious complications 5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug 6.Multiple malignancies 7. Pleural effusion or ascites requiring 8.Current or previous Brain metastasis 9.Diarrhea(watery stool) 10.Fresh bleeding of digestive organs 11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 14.Man of wanting child 15.Need Systemically administration of corticosteroids 16.Patients judged inappropriate for this study by the physicians

Design outcomes

Primary

MeasureTime frame
Rate of pathological complete response

Secondary

MeasureTime frame
Safety

Countries

Japan

Contacts

Public ContactKimihiko Funahashi

Division of general and gastroenterological surgery, Department of Surgery (Omori) Division of general and gastroenterological surgery, Department of Surgery (Omori)

kingkong@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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