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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017685 |
Receipt No. | R000019570 |
Scientific Title | Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer |
Date of disclosure of the study information | 2015/05/27 |
Last modified on | 2018/05/28 |
Basic information | ||
Public title | Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer | |
Acronym | UDON P-II | |
Scientific Title | Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer | |
Scientific Title:Acronym | UDON P-II | |
Region |
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Condition | |||
Condition | Esophageal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We evaluate the effectiveness of the 5FU/ docetaxel / nedaplatin combination therapy for the esophageal cancer that radical radiation therapy is impossible having a recurrence case or remote metastasis. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | response rate |
Key secondary outcomes | progression free survival
overall survival adverse event |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Combination chemotherapy consists of docetaxel (35 mg/m2/day, day 1 and day 15), nedaplatin (90 mg/m2/day, day 1), and 5-FU (800mg/m2/day, days 1 through 5). The treatment is repeated every 4 weeks until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. | |
Interventions/Control_2 | ||
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Interventions/Control_6 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction.
2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma. 3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy. a)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases ii)cT1-cT4a iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through b)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases. ii)Dysphagia score =<2. 4)Older than 20 years old. 5)ECOG PS of 0,1 or 2. 6)Measurable lesion is required. 7)Neither previous chemotherapy ,chemoradiotherapy,nor radiotherapy against any cancer 8)Adequate organ function 9)Without symptomatic brain metastasis 10)Without moderate or more ascites/pleural effusion 11)Written informed consent |
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Key exclusion criteria | 1)Poorly controlled diabetes mellitus or routine administration of insulin.
2)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 3)History of hypersensitivity to 5FU, DOC, CDGP, or polysorbate 80. 4)Active infection requiring systemic therapy. 5)Patients requiring systemic steroid medication. 6)Motor paralysis or peripheral neuropathy by any reason. 7)Edema by any reason. 8)Severe pulmonary fibrosis or emphysema. 9)A case with the past of radiotherapy or the chemotherapy within two weeks before registration. 10)With moderate or more ascites/pleural effusion or pericardial fluid. 11) Severe cardiac disease , or with a history of myocardial infarction within 6 months , or poorly controlled hypertension. 12)A case to have the past of the cerebrovascular disorder that developed within six months. 13)A case to have diarrhea continuously. 14)Case having the intestinal tract paralysis, ileus 15)Positive HBs antigen , or positive HIV antibody. 16)The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 17) During the pregnancy or a pregnant female patient we are possible or are nursing. |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kinki university Faculty of Medicine | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 377-2,ohnohigashi,osakasayamashi,osaka | ||||||
TEL | 072-366-0221 | ||||||
h-ueda@med.kindai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kinki University Faculty of Medicine | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 377-2,ohnohigashi,osakasayamashi,osaka | ||||||
TEL | 072-366-0221 | ||||||
Homepage URL | |||||||
h-ueda@med.kindai.ac.jp |
Sponsor | |
Institute | Kinki university Faculty of Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019570 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |