Unique ID issued by UMIN | UMIN000016364 |
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Receipt number | R000019003 |
Scientific Title | Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer |
Date of disclosure of the study information | 2015/02/01 |
Last modified on | 2022/08/04 16:53:50 |
Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Phase I/II trial of chemotherapy with modified DCS
Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Phase I/II trial of chemotherapy with modified DCS
Japan |
esophageal cancer
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
This phase I/II study is being conducted to determine the safety and the efficacy of chemotherapy using docetaxel, cisplatin and S-1 (DCS) for unresectable advanced esophageal cancer.
Safety,Efficacy
Exploratory
Phase I,II
Phase I: Safety (Toxicities as assessed by NCI CTCAE ver. 4)
Phase II: Clinical response of chemotherapy(Feasibility as evaluated by RECIST ver 1.1)
Phase II: Toxicities as assessed by NCI CTCAE ver. 4
Time to progression
Median survival time
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Chemotherapy using Docetaxel+Cisplatin+S-1
20 | years-old | <= |
85 | years-old | > |
Male and Female
(1)Patients with locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan.
(2)ECOG perfprmance status 0-1.
(3)Tissue from tumor must be available. Patients must have measurable disease.
(4)Patients may have received prior chemotherapy or radiotherapy; this must have beed completed at least 4 weeks. Patients may have received prior surgery or ESD; this must have beed completed at least 3 weeks. Patients may have received prior immunotherapy; this must have beed completed at least 1 week.
(5)Life expectancy > 3 months.
(6)Laboratory values as follows.
2000/mm3 < WBC < 12000/mm3
granulocyte count > 1500/mm3
hemoglobin > 8.0 g/dl
Platelet count > 100000/mm3
AST ALT < 150 IU/L
T-bil < 1.5 mg/dl
Creatinine < 1.5
(1)Pregnency.
(2)Active or uncontrolled infection.
(3)Patients with a history of myocardial infarction within the previous 3 months.
(4)Patients with uncontrolled diabetes melitus or hypertension.
(5)Patients with clinically apparent central nervous system metastases
(6)Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.
50
1st name | Toshiyasu |
Middle name | |
Last name | Ojima |
Wakayama Medical University
Second Department of Surgery
641-8510
811-1 Kimiidera, Wakayama, Japan
073-441-0613
tojima@wakayama-med.ac.jp
1st name | Toshiyasu |
Middle name | |
Last name | Ojima |
Wakayama Medical University
Second Department of Surgery
641-8510
811-1 Kimiidera, Wakayama, Japan
073-441-0613
tojima@wakayama-med.ac.jp
Second Department of Surgery, Wakayama Medical University
Second Department of Surgery, Wakayama Medical University
Self funding
Second Department of Surgery, Wakayama Medical University
Kimiidera 811-1
0734410613
tojima@wakayama-med.ac.jp
NO
2015 | Year | 02 | Month | 01 | Day |
Oncology 2018;95:116
Partially published
Oncotarget, 2019, Vol. 10, (No. 8), pp: 847-855
50
Results: In the phase I trial, the recommended dose for docetaxel, cisplatin, and
S-1 were 40 mg/m2 (day 1), 50 mg/m2 (day 1), and 80 mg/m2/day, respectively.
In the phase II trial (n = 50), the ORR was 54 %. The median OS and PFS were 10
and 4 months, respectively. Grade 3/4 adverse events included neutropenia (26%),
leukopenia (14%), anorexia (10%) and febrile neutropenia (6%).
2022 | Year | 08 | Month | 04 | Day |
2019 | Year | 01 | Month | 03 | Day |
Although triplet regimen of docetaxel, cisplatin, and 5-FU (DCF)
reportedly yields high response rates for metastatic squamous cell carcinoma of
the esophagus (SCCE), it has severe toxicity. In our previous phase II trial, grade
3/4 toxicities of neutropenia occurred in 68.8% of the patients. Development of
chemotherapeutic regimen that does not impair quality of life of the patients with
metastatic SCCE is therefore needed. A novel chemotherapeutic regimen combining
docetaxel, cisplatin, and alternate-day administration of S-1 (modified DCS) may be
associated with reduction of severe adverse effects.
This study is a single center phase I/II trial of chemotherapy using modified DCS regimen for patients with recurrent/unresectable SCCE. The phase I trial adopts a 3 plus 3 patient cohort dose-escalating study design. In the phase II trial, the primary endpoint is evaluation of the overall response rate (ORR).
Secondary endpoints are evaluation of drug-related toxicity, overall survival (OS),
and progression-free survival (PFS).
Grade 3/4 adverse events included neutropenia (26%), leukopenia (14%), anorexia (10%) and febrile neutropenia (6%).
In the phase II trial, the primary endpoint is evaluation of the overall response rate (ORR).
Secondary endpoints are evaluation of drug-related toxicity, overall survival (OS),
and progression-free survival (PFS).
Enrolling by invitation
2014 | Year | 12 | Month | 01 | Day |
2014 | Year | 05 | Month | 27 | Day |
2015 | Year | 02 | Month | 01 | Day |
2020 | Year | 01 | Month | 31 | Day |
2015 | Year | 01 | Month | 28 | Day |
2022 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019003
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