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Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Sonifilan
Type: Drug
Overall Status
Recruiting
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
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)
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Female
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
- 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
Location
JongHyeokKim
Seoul, Korea, Republic of
Status: Recruiting
Start Date
May 2013
Completion Date
May 2016
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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