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

Asan Medical Center

Status and phase: Enrolling; Phase 1

Conditions: Cervical Cancer

Treatments: Drug: Sonifilan

Study type: Interventional

Funder types: Other

Identifiers

NCT01926821

SIZO2013

Details and patient eligibility

About

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

Full 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)

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

sonifilan

Experimental group

Description:

Group who get sonifilan

Treatment:

Drug: Sonifilan

control

No Intervention group

Description:

No Sonifilan administered