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

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ClinicalTrials.gov Identifier: NCT01926821
Recruitment Status : Recruiting
First Posted : August 21, 2013
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Jong-Hyeok Kim, Asan Medical Center

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Sonifilan Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
Study Start Date : May 2013
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: sonifilan
Group who get sonifilan
 Drug: Sonifilan
Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
Other Names:
  • sizofiran inj 20mg
  • Code : XSISO
No Intervention: control
No Sonifilan administered


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: 3 year ]
    life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study


Secondary Outcome Measures :
  1. Complications of drug, treatment effects [ Time Frame: 3 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926821


Contacts
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Contact: WooSuk Han, Master 82-10-4818-9296 bronx46@hotmail.com

Locations
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Korea, Republic of
JongHyeokKim Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Study Chair: jongHyeok Kim, PhD Asan Medical Cneter
More Information
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Responsible Party: Jong-Hyeok Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01926821    
Other Study ID Numbers: SIZO2013
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Sizofiran
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents