NCT01926821

Brief Summary

The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy

  1. 1.Primary endpoint : Quality of life
  2. 2.Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

12.6 years

First QC Date

August 19, 2013

Last Update Submit

May 27, 2017

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life

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

    3 year

Secondary Outcomes (1)

  • Complications of drug, treatment effects

    3 year

Study Arms (2)

sonifilan

EXPERIMENTAL

Group who get sonifilan

Drug: Sonifilan

control

NO INTERVENTION

No Sonifilan administered

Interventions

SonifilanDRUG

Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times

Also known as: sizofiran inj 20mg, Code : XSISO
sonifilan

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cervical cancer FIGO stage IA2 - IVA
  • Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
  • GOG performance status 0-2

You may not qualify if:

  • past radiation therapy history
  • Neuroendocrine carcinoma
  • concurrent other cancer
  • uncontrolled medical disease
  • ulcerative disease history
  • current pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JongHyeokKim

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Sizofiran

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

beta-GlucansGlucansPolysaccharidesCarbohydrates

Study Officials

  • jongHyeok Kim, PhD

    Asan Medical Cneter

    STUDY CHAIR

Central Study Contacts

WooSuk Han, Master

CONTACT

82-10-4818-9296bronx46@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)