Unique ID issued by UMIN | UMIN000006305 |
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Receipt number | R000007466 |
Scientific Title | Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer. |
Date of disclosure of the study information | 2011/10/01 |
Last modified on | 2016/06/30 15:26:20 |
Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.
Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.
Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.
Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.
Japan |
Advanced or recurrent rectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Radiology |
Malignancy
NO
Phase I : To determine the maximum tolerated dose (MTD) and recommended dose (RD) of TS-1 / oxaliplatin / Radiation in patients with KRAS mutation type locally advanced and recurrent rectal cancer.
Phase II : To evaluate safety and efficacy of TS-1 / oxaliplatin / Radiation in patients with KRAS mutation type locally advanced and recurrent rectal cancer.
Safety,Efficacy
Phase I,II
Phase I : To determine maximum tolerated dose and recommended dose.
Phese II : pCR rate.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Radiotherapy with two parallel opposed lateral fields will be administered in fractions of 1.8 Gy/day, given 5 days per week for 25 days. The total dose of radiation will be 45 Gy.
TS-1 (80-120mg/day) will be given orally two times per day on Days 1-5, 8-12, 22-26, and 29-33. Oxaliplatin is administered intravenously at day 1 and day 22. The initial dose of Oxaliplatin was 75 mg/m2 (Level 1), given to 3 patients. The dose will be increased in a stepwise fashion, and 3 other patients will receive the next dose level until the MTD will be reached.
20 | years-old | <= |
Not applicable |
Male and Female
1) Histopathological confirmation of rectal cancer.
2)Locally advanced or recurrent cancer.
3) KRAS mutation type (codon12,13).
4) Previous chemotherapy completed at least 4 weeks before inclusion.
5) >=Age 20
6) ECOG performance status of 0 to 1.
7) Expected more than 3 months survival.
8) Sufficient function of important organs
1.Leu:4,000/mm3 to 12,000/mm3
2.Neu : >= 2,000 /mm3
3.Platelet : >= 100,000 /mm3
4.hemoglobin : >= 9.0 g/dL
5.AST, ALT : < 100 IU/L (<150 IU/L in case of liver metastasis)
6.St.bil : < 2.0 mg/dL
7.Ccr : >= 60 ml/min
9) Ability to ingestion intake and drug administration orally.
10) Informed consent is obtained.
1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
2) No radiation therapy
3) Allergic to a drug
4) Patients under treatment with flucytosine.
5) Sensory neuropathy
6) Metastasis to CNS.
7) Intestinal paralysis or ileus
8) Massive pleural or abdominal effusion.
9) Active infection and inflammation.
10) Watery stools or diarrhea.
11) Severe complications
12) Pregnant or lactating
13) Other patients who are unfit for the study as determined by the attending physician.
31
1st name | |
Middle name | |
Last name | Masataka Ikeda, Tsunekazu Mizushima |
Graduate School of Medicine, Osaka Univesity
Department of Surgery, Gastroenterolgical Surgery
2-2-E2, Yamadaoka, Suita, Osaka
06-6879-3251
mikeda@gesurg.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Masataka Ikeda, Tsunekazu Mizushima |
Graduate School of Medicine, Osaka Univesity
Department of Surgery, Gastroenterolgical Surgery
2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-3251
mikeda@gesurg.med.osaka-u.ac.jp
Graduate School of Medicine, Osaka Univesity
None
Self funding
Japan
NO
2011 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2011 | Year | 07 | Month | 14 | Day |
2011 | Year | 10 | Month | 01 | Day |
2014 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 07 | Day |
2016 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007466
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