UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014927 |
|---|---|
| Receipt number | R000017370 |
| Scientific Title | Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer |
| Date of disclosure of the study information | 2014/08/22 |
| Last modified on | 2017/08/24 14:53:24 |
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Basic information
Public title
Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Acronym
Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Scientific Title
Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Scientific Title:Acronym
Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence of dose limiting toxicity
Key secondary outcomes
Adverse events, overall survival, progression free survival, response rate, complete response rate
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
| Medicine | Maneuver |
Interventions/Control_1
Current chemoradiotherapy with PTX, CDDP, and 5-FU
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 squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage I or II or III or IV (with supraclavicular LN)
4) Total radiation dose is 50.4Gy
5) Aged 20 to 75 years old
6) ECOG PS of 0 or1
7) no need for measurable lesion
8) no previous treatment of esophageal cancer except EMR or ESD
9) no previous chemotherapy or radiotherapy against any other malignancies
10) adequate organ functions
11) refused esophagectomy
12) written informed consent
Key exclusion criteria
1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage I or II or III or IV (with supraclavicular LN)
4) Total radiation dose is 50.4Gy
5) Aged 20 to 75 years old
6) ECOG PS of 0 or1
7) no need for measurable lesion
8) no previous treatment of esophageal cancer except EMR or ESD
9) no previous chemotherapy or radiotherapy against any other malignancies
10) adequate organ functions
11) refused esophagectomy
12) written informed consent
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Muro |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoo Nomura |
Organization
Kyoto university
Division name
Department of Therapeutic Oncology
Zip code
Address
54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL
075-751-3518
Homepage URL
mnomura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 08 | Month | 22 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 22 | Day |
Last modified on
| 2017 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017370
