Trials / Unknown
UnknownNCT01926821
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- Female
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sonifilan | Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2013-08-21
- Last updated
- 2017-05-31
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01926821. Inclusion in this directory is not an endorsement.