NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051180039

Registered date:30/01/2019

Preoperative CRT using IMRT for LARC

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedLocally advanced rectal cancer
Date of first enrollment17/02/2017
Target sample size15
Countries of recruitment
Study typeInterventional
Intervention(s)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) Operation

Outcome(s)

Primary OutcomeThe rate of grade 2 acute gastrointestinal toxicity
Secondary OutcomeThe rate of more than grade 2 acute diarrhea, the rate of more than grade 3 acute diarrhea, the rate of acute gastrointestinal toxicity based on the patient reported outcome, the rate of acute adverse events, the rate of late adverse events, overall survival, progression-free survival, the rate of pathological complete response, the rate of the completion of the planned treatment, the rate of decreased therapeutic intensity, the rate of R0 resection, the rate of down staging, the rate of the surgery associated complication

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Katsuyuki Sakanaka
Address 54 Sho-goin Kawahara cho, Sakyo-ku, Kyoto, Kyoto Kyoto Japan 606-8507
Telephone +81-75-751-3762
E-mail sakanaka@kuhp.kyoto-u.ac.jp
Affiliation Kyoto university
Scientific contact
Name Takashi Mizowaki
Address 54 Sho-goin Kawahara cho, Sakyo-ku, Kyoto, Kyoto Kyoto Japan 6068507
Telephone +81-75-751-3762
E-mail mizo@kuhp.kyoto-u.ac.jp
Affiliation Kyoto university