UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013056 |
|---|---|
| Receipt number | R000015232 |
| Scientific Title | chemotherapy for soft tissue sarcoma |
| Date of disclosure of the study information | 2014/02/04 |
| Last modified on | 2018/08/10 14:01:59 |
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Basic information
Public title
chemotherapy for soft tissue sarcoma
Acronym
chemotherapy for soft tissue sarcoma
Scientific Title
chemotherapy for soft tissue sarcoma
Scientific Title:Acronym
chemotherapy for soft tissue sarcoma
Region
| Japan |
Condition
Condition
soft tissue sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety and efficacy of radio-hyperthermo-chemotherapy for soft tissue sarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
local response
Key secondary outcomes
adverse effect, overall survival
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
Chemotherapy was given by intra-arterial infusion using the reservoir, and consisted of cisplatin (3 mg/kg) in conjunction with the first, third, and fifth hyperthermia sessions and pinorubin (an adriamycin derivative; 1 mg/kg) in conjunction with the second and fourth hyperthermia sessions. Two weeks after five sessions of RHC had been completed, patients received systemic chemotherapy (primarily ifosfamide), followed by surgery. Chemotherapeutic agents were administered continuously via the reservoir from the start of hyperthermia until approximately 1.5 hours after hyperthermia was completed. Radiotherapy involved the delivery of radiation at a dose of 2 Gy, 5 days per week, over 16 sessions, for a total dose of 32 Gy. Irradiation was performed immediately before hyperthermia and chemotherapy. Hyperthermia was conducted using an 8-MHz radiofrequency capacitive heating system (Thermotron RF-8; Yamamoto Vinyter, Osaka, Japan). The temperature was measured by insertion of a hyperthermia needle into the scar tissue and insertion of a thermocouple thermometer (0.64-mm f) into the space. The objective of treatment was to achieve a temperature of 42.5 degree for 60 minutes. The treatment protocol involved five sessions, consisting of four sessions of RHC followed by one session of hyperthermia and chemotherapy.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed soft tissue sarcoma
PS 0 to 2
Informed consent is obtained
Inpatient
Key exclusion criteria
WBC<3000/ul
Neutrophil <1500/ul
Plt<75000/ul
Hb < 7g/ul
CCr< 60ml/min
AST/ALT > 75IU/l(male),67.5IU/l(female)
T-Bil > 3.0mg/dl
No documented consent
EF<50%
allergy for planned drugs
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamada |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Orthopaedic Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601 JAPAN
TEL
052-853-8236
syamada@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamada |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Orthopaedic Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601 JAPAN
TEL
052-853-8236
Homepage URL
syamada@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
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
| 2014 | Year | 02 | Month | 04 | 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 | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015232
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
