UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025109 |
|---|---|
| Receipt number | R000028853 |
| Scientific Title | A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/05/22 16:37:17 |
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Basic information
Public title
A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma
Acronym
A phase II study of mDNF-R followed by S-1 maintenance therapy and salvage therapy for patients with esophageal carcinoma
Scientific Title
A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma
Scientific Title:Acronym
A phase II study of mDNF-R followed by S-1 maintenance therapy and salvage therapy for patients with esophageal carcinoma
Region
| Japan |
Condition
Condition
Esophageal carcinoma
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
(1) To confirm the efficacy and safety of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation followed by S-1 maintenance therapy
(2) To confirm the safety of salvage therapy for patients with recurrent lesion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year progression free survival
Key secondary outcomes
Overall survival
Safety
Radiation related adverse events
Salvage therapy related adverse events
Response rate
Completion rate for S-1 maintenance therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Definitive chemoradiation therapy using docetaxel, nedaplatin and 5-fluorouracil (DNF) with concurrent radiotherapy (50.4 Gy) followed by 2-course of additional DNF therapy and 1-year S-1 maintenance therapy.
2) Salvage therapy for patients with recurrent lesion
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) histologically proven thoracic esophageal cancer (UICC-TMN, 7th)
(2) clinical stage IB-III (nonT4) (UICC-TMN, 7th)
(3) no prior chemotherapy and radiotherapy
(4) age 20-75 years
(5) an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
(6) adequate baseline bone marrow function, adequate hepatic function, adequate renal function, adequate respiratory and cardiac function
(7) no prior endoscopic or surgical resection for esophageal cancer
(8) patients who are deemed to be tolerable for surgery, but refuse surgery as initial treatment modality
(9) able to intake orally
(10) a life expectancy of at least 3 months
(11) written informed consent was obtained from all patients
Key exclusion criteria
(1) prior chemotherapy and radiotherapy
(2) history of drug hypersensitivity
(3) contraindication for docetaxel, nedaplatin , 5-FU, or G-CSF
(4) active concomitant malignancy.
(5) severe heart disease
(6) severe diabetes mellitus, severe hypertension, active infection
(7) interstitial pneumonia or pulmonary fibrosis
(8) pregnant or lactating females
(9) high fever
(10) the investigator considers not suitable for the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohnuma |
Organization
Sapporo Medical University
School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
S1W16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
ohnuma@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohnuma |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
S1W16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
ohnuma@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine, Department of Medical Oncology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028853
