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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926821

Enrollment

200

Registered

2013-08-21

Start date

2013-05-31

Completion date

2025-12-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Brief 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

Detailed description

Study design Prospective randomized controlled trial 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)

Interventions

DRUGSonifilan

Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Complications of drug, treatment effects	3 year

Countries

South Korea

Contacts

Primary ContactWooSuk Han, Master

bronx46@hotmail.com82-10-4818-9296

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026