Cervical CancerPhase 1NCT01926821
Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
A Phase 1 study testing Sonifilan in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy 1. Primary endpoint : Quality of life 2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Sonifilan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical cancer FIGO stage IA2 - IVA
- Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
- GOG performance status 0-2
Who cannot join
- past radiation therapy history
- Neuroendocrine carcinoma
- concurrent other cancer
- uncontrolled medical disease
- ulcerative disease history
- current pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
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
Read the detailed description
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
- 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
- Cervical Cancer
- Being tested
- Sonifilan
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonifilanDrug
Also called sizofiran inj 20mg, Code : XSISO
Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
| Study group | Role | What they receive |
|---|---|---|
| sonifilan | Experimental | Group who get sonifilan Receives: Drug: Sonifilan |
| control | No intervention | No Sonifilan administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study
Measured: 3 year
Secondary outcomes (1)
Complications of drug, treatment effects
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Hyeok Kim, Asan Medical Center
- Investigators
- jongHyeok Kim, PhD, Study chair, Asan Medical Cneter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926821
- Sponsor's protocol ID
- SIZO2013
- Status last verified
- May 2017
- First submitted
- 19 Aug 2013
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
- ClinicalTrials.gov ID
- NCT01926821
- Acronym / sponsor ID
- SIZO2013
- Conditions
- Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sonifilan | Experimental | Drug: SonifilanGroup who get sonifilan |
| control | No intervention | –No Sonifilan administered |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cervical cancer FIGO stage IA2 - IVA
- Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
- GOG performance status 0-2
Key exclusion criteria (6 listed)
- past radiation therapy history
- Neuroendocrine carcinoma
- concurrent other cancer
- uncontrolled medical disease
- ulcerative disease history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonifilanAlso: sizofiran inj 20mg, Code : XSISOSonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times | Drug | sonifilan |
Primary outcome
Quality of life
Time frame: 3 year
life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study
1 secondary outcome
Complications of drug, treatment effects
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jongHyeok Kim, PhD study chair
Asan Medical Cneter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sonifilan in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WooSuk Han, Master (82-10-4818-9296, bronx46@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.