Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
- Registration Number
- NCT01926821
- Lead Sponsor
- Asan Medical Center
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Cervical cancer FIGO stage IA2 - IVA
- Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
- GOG performance status 0-2
- past radiation therapy history
- Neuroendocrine carcinoma
- concurrent other cancer
- uncontrolled medical disease
- ulcerative disease history
- current pregnancy and lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sonifilan Sonifilan Group who get sonifilan
- Primary Outcome Measures
Name Time Method Quality of life 3 year life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study
- Secondary Outcome Measures
Name Time Method Complications of drug, treatment effects 3 year
Trial Locations
- Locations (1)
JongHyeokKim
🇰🇷Seoul, Korea, Republic of