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Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sonifilan
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • JongHyeokKimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

sonifilan

control

Arm Description

Group who get sonifilan

No Sonifilan administered

Outcomes

Primary Outcome Measures

Quality of life
life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study

Secondary Outcome Measures

Complications of drug, treatment effects

Full Information

First Posted
August 19, 2013
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01926821
Brief Title
Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
Official Title
The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Recruiting
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed 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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sonifilan
Arm Type
Experimental
Arm Description
Group who get sonifilan
Arm Title
control
Arm Type
No Intervention
Arm Description
No Sonifilan administered
Intervention Type
Drug
Intervention Name(s)
Sonifilan
Other Intervention Name(s)
sizofiran inj 20mg, Code : XSISO
Intervention Description
Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
Primary Outcome Measure Information:
Title
Quality of life
Description
life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Complications of drug, treatment effects
Time Frame
3 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WooSuk Han, Master
Phone
82-10-4818-9296
Email
bronx46@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jongHyeok Kim, PhD
Organizational Affiliation
Asan Medical Cneter
Official's Role
Study Chair
Facility Information:
Facility Name
JongHyeokKim
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy

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