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

May 27, 2017 updated by: Jong-Hyeok Kim, Asan Medical Center

The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3 year
life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications of drug, treatment effects
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Chair: jongHyeok Kim, PhD, Asan Medical Cneter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIZO2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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