Preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer: single institutional pilot study

Preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer: single institutional pilot study - Preoperative chemoradiotherapy using IMRT for locally advanced rectal cancer: pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024549

Enrollment

Registered

2016-11-01

Start date

2017-01-18

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

Rectal cancer

Interventions

1) Preoperative chemoradiotherapy i) Intensity-modulated radiotherapy: 45 Gy/25frs/5weeks ii) S-1 80-120mg/body, p.o (days 1-5, 8-12, 22-26, 29-33), CPT-11, 60 mg/m2, div (days 1, 8, 22, 29) 2) O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcionma 2) Resectable rectal cancer i) clinically T3-4 and N0-2 ii) Ra or Rb iii) Inferior margin of tumor is located below the peritoneal reflection 3) No hepatic, peritoneal metastasis 4) 20-80 years 5) Performance Status: 0-2 6) No previous treatment 7) Adequate organ function 8) Able to take drugs orally 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Active other synchronous cancer 2) Receiving flucytosin or atazonavi 3) Suffering the active infection 4) Uncontrollable comorbidity 5) Pregnant or breastfeeding women, 6) Reciving steroid medication 7) Difficult to join due to mental disorder

Design outcomes

Primary

Measure	Time frame
The rate of grade 2 acute gastrointestinal toxicity	—

Countries

Japan

Contacts

Public ContactKatsuyuki Sakanaka

Kyoto university graduate school of medicine Department of radiation oncology and image-applied therapy

sakanaka@kuhp.kyoto-u.ac.jp075-751-3762

Outcome results

None listed

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