A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer.

A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer. - A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer. (PRESENTER)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006242

Enrollment

Registered

2011-08-28

Start date

2011-04-01

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

Radiation 1.8Gy/day 25 times(5 weeks) Total radiation 45Gy. Consisting of 5 weeks and 5 consecutive days of radiation followed by 2 days off. TS-1 80-120 mg/m2 orally twice daily on days 1-14 ever

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histopathological confirmation of lower rectal cancer(Adenocarcinoma) (2) locally-advanced and recurrent lower rectal cancer. (3) Distant metastasis (4) No prior chemotherapy (5) Over age 20 (6) ECOG performance status of 0,1 (7) Life expectancy more than 3 months (8) A good condition of important organs (9) Sufficient organ functions (10) Oral administration is possible (11) Written informed consent

Exclusion criteria

Exclusion criteria: (1) History of other malignancy,except for curatively treated carcinoma in situ or intramucosal carcinoma (Subjects with other malignancies who have been disease-free for at least 5 years are eligible.) (2) Patients who have undergone radiotherapy (3) Patients with diarrhea (4) Patient with regular use of furucytocin (5) Patients with severe complications,(severe cardiovascular disease,severe heart disease,heart failure,liver failure,renal failure or uncontrollable diabetes mellitus) (6) Patients with uncontrollable ascites and pleural effusion (7) The case suspected of infection with feaver (over 38 centigrade). (8) Serious drug hypersensitivity (9) Patients with paralytic ileus, bowel obstruction (10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. (11) Any other cases who are regarded as inadequate for study enrollmet by investigators

Design outcomes

Primary

Measure	Time frame
Histological response evaluation	—

Secondary

Measure	Time frame
Tumor regression grading Accomplishment rate Response rate Progression free survival Overall survival Incidence and degree of adverse events R0-resection rate Sphincter preservation Down Staging rate	—

Countries

Japan

Contacts

Public ContactKotaro Kitani

Nara Hospital Kinki University Faculty of Medicine Surgery

0743-77-0880

Outcome results

None listed

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