UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	chemotherapy for soft tissue sarcoma
Title of the study (Brief title)	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	Satoshi Yamada
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Orthopaedic Surgery
Address	1 Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601 JAPAN
TEL	052-853-8236
Email	syamada@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Satoshi Yamada
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Orthopaedic Surgery
Address	1 Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601 JAPAN
TEL	052-853-8236
Homepage URL
Email	syamada@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015232