Overview
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
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)
Eligibility
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