Cervical Cancer Clinical Trial
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
1. Primary endpoint : Quality of life
2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan
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)
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