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NCT01926821 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01926821
Other study ID # SIZO2013
Secondary ID
Status Recruiting
Phase Phase 1
First received August 19, 2013
Last updated May 27, 2017
Start date May 2013
Est. completion date December 2025

Study information
Verified date May 2017
Source Asan Medical Center
Contact WooSuk Han, Master
Phone 82-10-4818-9296
Email bronx46@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of JongHyeokKim Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life life quality assessment by filling out EORTC QOQ-C30, CX24, SF-36, FSFI pre-/on-/post-study 3 year
Secondary Complications of drug, treatment effects 3 year
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