NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180291

Registered date:15/03/2019

Preoperative chemoradiotherapy for advanced rectal cancer

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedRectal or anal cancer
Date of first enrollment01/03/2017
Target sample size50
Countries of recruitment
Study typeInterventional
Intervention(s)We select patients by CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens, and treat them with preoperative CRT listed below. S-1(80mg/m2/day1-5,8-12,22-26,29-33) irinotecan(60mg/m2/day1,8,22,29) Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)

Outcome(s)

Primary OutcomeComplete Response Rate
Secondary Outcome1) Local recurrence free survival 2) Relapse free survival (RFS) 3) Overall survival (OS)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria(1) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III. (2) Histologically confirmed adenocarcinoma (3) Without prior anti-tumor therapy (4) Age:20-80years old (5) Performance status 0-2 (6) Adequate organ function WBC>= 4,000 <= 15,000/mm3 neutro>= 2,000/mm3 Plt>= 100,000/mm3 Hb>= 8.0g/dl Cr<= 1.5mg/dl T-Bil<= 1.5mg/dl AST, ALT<= double of the upper limit (7) Written IC with date
Exclude criteria(1) Severe diabetes (2) Severe hypertension (3) Interstitial pneumonitis, pulmonary fibrosis, severe pulmonary emphysema (4) Active chronic hepatitis B or C (5) Blood Transfusion within the last 2 weeks (6) Patients with mental diseases judged inappropriate for this study by the physicians (7) Without written IC with date (8) Contraindication for taking CPT-11 (9) Contraindication for taking S-1 (10) Patients judged inappropriate for this study by the physicians

Related Information

Contact

Public contact
Name Masato Yamadera
Address 3-2 Namiki, Tokorozawa, Saitama Saitama Japan 359-8513
Telephone +81-4-2995-1637
E-mail yamadera@ndmc.ac.jp
Affiliation National Defense Medical College Hospital
Scientific contact
Name Hideki Ueno
Address 3-2 Namiki, Tokorozawa, Saitama Saitama Japan 359-8513
Telephone +81-4-2995-1637
E-mail ueno_surg1@ndmc.ac.jp
Affiliation National Defense Medical College Hospital