JRCT ID: jRCTs031180291
Registered date:15/03/2019
Preoperative chemoradiotherapy for advanced rectal cancer
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Rectal or anal cancer |
Date of first enrollment | 01/03/2017 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Complete Response Rate |
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Secondary Outcome | 1) Local recurrence free survival 2) Relapse free survival (RFS) 3) Overall survival (OS) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 80age old |
Gender | Both |
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
Primary Sponsor | Ueno Hideki |
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Secondary Sponsor | |
Source(s) of Monetary Support | The Japan Society for the Promotion of Science (JSPS) |
Secondary ID(s) | UMIN000026306 |
Contact
Public contact | |
Name | Masato Yamadera |
Address | 3-2 Namiki, Tokorozawa, Saitama Saitama Japan 359-8513 |
Telephone | +81-4-2995-1637 |
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 |
ueno_surg1@ndmc.ac.jp | |
Affiliation | National Defense Medical College Hospital |