UMIN-CTR Clinical Trial

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

Patients with radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy

Classification by specialty

Obstetrics and Gynecology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagoya University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

05

Month

07

Day

Last modified on

2016

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020218