Unique ID issued by UMIN | UMIN000028589 |
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Receipt number | R000032500 |
Scientific Title | Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer |
Date of disclosure of the study information | 2017/08/08 |
Last modified on | 2017/08/08 19:27:57 |
Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer
Phase I study of definitive CRT with PCF (PCF-RT) for clinical stage IA-IIIC esophageal cancer
Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer
Phase I study of definitive CRT with PCF (PCF-RT) for clinical stage IA-IIIC esophageal cancer
Japan |
esophageal cancer
Gastroenterology |
Malignancy
NO
To estimate the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT), and to determine the recommended dose (RD) of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU for clinical stage IA-IIIC esophageal cancer.
Safety
Confirmatory
Explanatory
Phase I
Incidence of dose limiting toxicity
Adverse events (AE), complete response rate (CRR), progression-free survival (PFS), overall survival(OS)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
chemoradiotherapy with paclitaxel, CDDP and 5-FU
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma or basaloid carcinoma of the esophagus
2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
3) Aged 20 to 80 years old
4) ECOG PS of 0 or 1
5) Clinical stage IA-IIIC (UICC-TNM ver.7.0)
6) No need for measurable lesion
7) No previous treatment of esophageal cancer except EMR or ESD
8) No palsy of recurrent nerve
9) Refused esophagectomy
10) Adequate organ functions
11) Written informed consent
1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
2) History of radiotherapy for mediastinum
3) Uncontrollable diabetes millutus
4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure
5) Uncontrollable arrhythmia
6) Patients requiring systemic steroids medication
7) Liver cirrhosis
8) Active bacterial or fungous infection
9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
10) With grade 2-4 nerve disturbance by CTCAE version 4.0
11) With blood transfusion within 2 weeks and/or active bleeding
12) Interstitial pneumonia, fibroid lung or severe emphysema
13) With a history of allergic reaction to polyoxy-ethilen oil, hydrogenated castor oil or polysorbate 80
14) Psychosis
15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study
24
1st name | |
Middle name | |
Last name | Yamamoto Sachiko |
Osaka international cancer institute
Gastrointestinal oncology
3-1-69, Otemae, Osaka-city, Osaka, 541-8567 Japan
06-6945-1181
yamamoto-sa@mc.pref.osaka.jp
1st name | |
Middle name | |
Last name | Yamamoto Sachiko |
Osaka international cancer institute
Gastrointestinal oncology
3-1-69, Otemae, Osaka-city, Osaka, 541-8567 Japan
06-6945-1181
yamamoto-sa@mc.pref.osaka.jp
Osaka international cancer institute
Osaka international cancer institute
Other
None
None
NO
大阪国際がんセンター(大阪府)
2017 | Year | 08 | Month | 08 | Day |
Unpublished
Preinitiation
2017 | Year | 07 | Month | 12 | Day |
2017 | Year | 07 | Month | 26 | Day |
2017 | Year | 08 | Month | 08 | Day |
2017 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032500
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