Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
NCT ID: NCT01926821
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2013-05-31
2025-12-31
Brief Summary
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1. Primary endpoint : Quality of life
2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan
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Detailed Description
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Study period Protocol registration approval date - may/31/2016
Study drug Sonifilan(Sizofiran)
Study population
1. Cervical cancer FIGO stage IA2-IVA patients will be participated.
2. Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
3. age 20-75 year
Treatment Fron the day of radiation therapy started, Sonifilan 20mg, 1amp IM/week for 8weeks
Concurrent therapy Chemo \& radiation therapy
1. Cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36
2. External whole pelvic irradiation 3000-3500 cGy / 6 fractions in high dose rate
Assessment
1. Pre-study assessment (within 4weeks before participation) a medical history b informed consent c ID number assignment d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI e basic information collect
2. On-study assessment (during study) a complication check b life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI
3\. Post-study assessment (1week after study finished) a MRI b PAP smear c HPV test d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI
4 Follow-up assessment (every 3 month for 1 year) a Pelvic exam b PAP smear c HPV test d MRI (if needed) e PET (if needed) f life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI 93, 6, 12, 24 month after study finished)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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sonifilan
Group who get sonifilan
Sonifilan
Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
control
No Sonifilan administered
No interventions assigned to this group
Interventions
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Sonifilan
Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
* GOG performance status 0-2
Exclusion Criteria
* Neuroendocrine carcinoma
* concurrent other cancer
* uncontrolled medical disease
* ulcerative disease history
* current pregnancy and lactation
20 Years
75 Years
FEMALE
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Jong-Hyeok Kim
Professor
Principal Investigators
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jongHyeok Kim, PhD
Role: STUDY_CHAIR
Asan Medical Cneter
Locations
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JongHyeokKim
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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SIZO2013
Identifier Type: -
Identifier Source: org_study_id
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