UMIN-CTR Clinical Trial

Basic information
Public title	Laser thermotherapy for radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy
Acronym	Laser thermotherapy for radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy
Scientific Title	Laser thermotherapy for radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy
Scientific Title:Acronym	Laser thermotherapy for radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy
Region	Japan

Condition
Condition	Patients with radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy
Classification by specialty	Obsterics and gynecology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical safety and performance testing of the newly developed laser thermotherapy equipment for patients with radioresistant cervical cancer after radiotherapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of safety -Measured by incidence of adverse events before, in and after treatment and until 6 months after the treatment.
Key secondary outcomes

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	Device,equipment Maneuver
Interventions/Control_1	The newly developed laser thermotherapy equipment 1. Thermotherapy is one time a week. 2. Heating time is from 40 to 50 minutes at 43-45 degrees. 3. Thermotherapy is done 5 or 6 times.
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	Not applicable
Gender	Female
Key inclusion criteria	(1)A patient with superficial lesion and a little tumor amount. (2)A patient with no recurrent lesion except for recurrence of uterine cervix in pelvis, or a patients with an expected survival of more than 6 months after this treatment. (3)A patient without distant metastasis. (4))A patient with difficulty of additional radiation therapy. (5)A patient with difficulty of operation or with refusal of operation. (6)A patient without indication of chemotherapy or with refusal of chemotherapy. (7)A patient who has been diagnosed with recurrent or residual cancer of the uterine cervix based on histology (biopsy). (8)A patient who has squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma is limited. (9)A patient with an expected survival of more than 6 months. (10)A female patient aged 20 years or older at the time of enrollment and a patient who has provided written informed consent to partcipate in this study.
Key exclusion criteria	(1)A patient who cannot be inserted this equipment through the vagina and can be hard to attain to a lesion. (2)A patient with collagen disease. (3)A patient with active double cancer. (4)A patient whom the investigator considers to be ineligible as a subject.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiyuki Itoh
Organization	Nagoya University Graduate School of Medicine
Division name	Therapeutic Radiology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2544
Email	itoh@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshiyuki Itoh
Organization	Nagoya University Hospital
Division name	Dept. of Radiology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2328
Homepage URL
Email	itoh@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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
Email

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	2015 Year 08 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	Preinitiation
Date of protocol fixation	2015 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 01 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	2015 Year 05 Month 07 Day
Last modified on	2016 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020218

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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