Unique ID issued by UMIN | UMIN000003701 |
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Receipt number | R000004484 |
Scientific Title | Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population. |
Date of disclosure of the study information | 2010/06/07 |
Last modified on | 2011/12/05 09:36:07 |
Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.
Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.
Japan |
rectal cancer
Gastrointestinal surgery |
Malignancy
NO
The efficacy of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer had already been shown in western countries. The aim of this study, phase I/II trial, is to assess safety and efficacy of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Safety
Safety
Side effect including clinical symptoms and blood examination.
Efficacy
Pathologic complete response rate, pathological downstaging, sphincter preservation, survival, local recurrence, urinary disorder, and anorectal disorder.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Stage II and III respectable locally advanced rectal cancer confirmed with colonoscopy, endoscopic ultrasonography, computed tomography, and magnetic resonance imaging.
2. ECOG performance status: 0-2.
3. Age: 20-80.
4. White blood cells: 2000/mm3-15000/mm3, Platelet >7.5/mm3, GPT <150IU/L, T-bil <3.0g/dL.
5. patient providing informed consent.
1. Stage IV rectal cancer, rectal cancer with bowel obstruction.
2. Pregnancy.
3. Lactation.
4. Pregnancy attempy.
5. Infectious diseases.
6. Use of immunosuppressive drug and steroid.
7. Double cancer.
8. Injury and wound.
9. Paralytic ileus and interstitial pneumonia.
10. Doctor's exclusion decision.
38
1st name | |
Middle name | |
Last name | Hiroki Yamaue |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera, Wakayama 641-8510 Japan
073(447)2300(5112)
1st name | |
Middle name | |
Last name | Shozo Yokoyama |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera, Wakayama 641-8510 Japan
073(447)2300(5112)
yokoyama@wakayama-med.ac.jp
Wakayama Medical University, Second Department of Surgery
Wakayama Medical University, Second Department of Surgery
Self funding
NO
2010 | Year | 06 | Month | 07 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 04 | Month | 24 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 06 | Month | 03 | Day |
2011 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004484
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