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Trial Title:
Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
NCT ID:
NCT01926821
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Sizofiran
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Sonifilan
Description:
Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
Arm group label:
sonifilan
Other name:
sizofiran inj 20mg
Other name:
Code : XSISO
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)
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
JongHyeokKim
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Start date:
May 2013
Completion date:
December 2025
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01926821
