Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy

Study Overview
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Brief Summary
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The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy Primary endpoint : Quality of life Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan

Detailed Description
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Study design Prospective randomized controlled trial Study period Protocol registration approval date - may/31/2016 Study drug Sonifilan(Sizofiran) Study population Cervical cancer FIGO stage IA2-IVA patients will be participated. Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma age 20-75 year Treatment Fron the day of radiation therapy started, Sonifilan 20mg, 1amp IM/week for 8weeks Concurrent therapy Chemo & radiation therapy Cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36 External whole pelvic irradiation 3000-3500 cGy / 6 fractions in high dose rate Assessment 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 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)

Official Title
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The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Sonifilan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical cancer FIGO stage IA2 - IVA Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma GOG performance status 0-2 Exclusion Criteria: past radiation therapy history Neuroendocrine carcinoma concurrent other cancer uncontrolled medical disease ulcerative disease history current pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sonifilan<br>Group who get sonifilan | Drug: Sonifilan<br>* Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times<br>* Other names: Code : XSISO;|
| No Intervention: control<br>No Sonifilan administered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of drug, treatment effects |  | 3 year |