Unique ID issued by UMIN | UMIN000007408 |
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Receipt number | R000008729 |
Scientific Title | Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer |
Date of disclosure of the study information | 2012/02/29 |
Last modified on | 2012/02/29 16:05:35 |
Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer
Phase II Trial of neoadjuvant chemotherapy with DCF for
esophageal cancer
Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer
Phase II Trial of neoadjuvant chemotherapy with DCF for
esophageal cancer
Japan |
esophageal cancer
Surgery in general |
Malignancy
NO
This phase I/II study is being conducted to determine the safety and the efficacy of neoadjuvant chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) for stage II/III esophageal cancer.
Safety,Efficacy
Exploratory
Phase II
Pathological response
Curative resection rate
Clinical response of chemotherapy
Postoperative complication
2y survival rate
3y survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Chemotherapy using docetaxel+Cisplatin+5-FU
Surgical resection
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Patients who are going to undergo curative esophagectomy with 2F or 3F lymph node dissection
2)TNM stage II/III
3)ECOG performance status 0-1
4)20 years and older, 75 years and younger
5)Patients must have histologic confirmation of the diagnosis with tumor
6)Patients have not received prior chemotherapy nor chemoradiotherapy
7)Laboratory values as follows;
3000/mm3 < WBC < 12000/mm3
1500/mm3 < granulocyte count
8.0 gm/dl < hemoglobin
Platelet count > 100000/mm3
Aspartate transaminase < 150 IU/L
Alanine transaminase < 150 IU/L
Creatinine < 1.5 mg/dl
8)Able and willing to give valid written informed consent
Different histological type from squamous cell carcinoma or adenocarcinoma
Patient with allergic response to anticancer drugs (docetaxel, cisplatin, 5-FU)
Active or uncontrolled infection
Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
Clinically significant heart disease
Patients with a history of myocardial infarction within the previous three months
Patients with uncontrolled diabetes mellitus or hypertension
Patients with interstitial pneumonia or pulmonary fibrosis
Patients who receive hemodialysis
Presence of clinically apparent central nervous system metastases
Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
Decision of unsuitableness by principal investigator or physician-in-charge
40
1st name | |
Middle name | |
Last name | Makoto Iwahashi |
Wakayama Medical Unversity
Second Department of Surgery
Kimiidera, Wakayama, Japan
1st name | |
Middle name | |
Last name | Makoto Iwahashi |
Wakayama Medical University
Second Department of Surgery
makoto@wakayama-med.ac.jp
Second Department of Surgery, Wakayama Medical University
Second Department of Surgery, Wakayama Medical University
Self funding
NO
2012 | Year | 02 | Month | 29 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 04 | Month | 20 | Day |
2011 | Year | 06 | Month | 01 | Day |
2012 | Year | 02 | Month | 29 | Day |
2012 | Year | 02 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008729
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