Adjuvant Chemotherapy for Locally Advanced Cervical Cancer
Conditions
Uterine Cervical Cancer - (FIGO Stage IIB-IVA)
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Locally advanced cervical cancer, Concurrent chemoradiation, Adjuvant chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Pelvic radiation Type: Radiation
Name: Cisplatin Type: Drug
Name: Paclitaxel Type: Drug
Name: Carboplatin Type: Drug
Overall Status
Not yet recruiting
Summary
Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.
Detailed Description
Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.

This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Age 18-70 years

- Cervical cancer FIGO stage IIB-IVA

- Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma

- ECOG performance status 0-2

- No history of other cancer except basal cell carcinoma

- Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)

- Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl

- Consent to participate

Exclusion Criteria:

- Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI

- Adnexal mass from physical examination or imaging study

- Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.

- Pregnancy or lactation
Locations
Bhumibol Adulyadej Hospital
Bangkok, Thailand
Status: Not yet recruiting
Contact: Thanomsiri SoonThornthum, MD - 66-81-6896927 - tan270314@yahoo.com
Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University
Bangkok, Thailand
Status: Not yet recruiting
Contact: Siriwan Tangjitgamol, MD - 66-86-3841431 - siriwanonco@yahoo.com
Department of Radiology, Department of Obsterics and Gynecology, Chulalongkorn University
Bangkok, Thailand
Status: Not yet recruiting
Contact: Chonlakiet Khorprasert, MD - 66-89-1374951 - chonlakiet@gmail.com
Health Intervention and Technology Assessment Program
Bangkok, Thailand
Status: Not yet recruiting
Contact: Yot Teerawattananon, MD - 66-84-6760080 - yot.t@hitap.net
Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University
Chiang Mai, Thailand
Status: Not yet recruiting
Contact: Ekkasit Tharavijitkul, MD - 966-89-4338709 - paan_31@hotmail.com
Chonburi Cancer Hospital
Chonburi, Thailand
Status: Not yet recruiting
Contact: Chokaew Tovanabutra, MD - 66-81-4726633 - chokaewt@hotmail.com
Lampang Cancer Hospital
Lampang, Thailand
Status: Not yet recruiting
Contact: Tussawan Asakit, MD - 66-81-6715013 - tussawan_a1@hotmail.com
Lopburi Cancer Hospital
Lopburi, Thailand
Status: Not yet recruiting
Contact: Jirasak Sukhaboon, MD - 66-89-7970600 - fodjiji@gmail.com
Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University
Songkla, Thailand
Status: Not yet recruiting
Contact: Jitti Hanprasertpong, MD - 66-89-6540214 - hjitti@medicine.psu.ac.th
Ubonratchathani Cancer Hospital
Ubonratchathani, Thailand
Status: Not yet recruiting
Contact: Taywin Chottetanaprasith, MD - 66-81-9359756 - taywinc@hotmail.com
Udonthani Cancer Hopital
Udonthani, Thailand
Status: Not yet recruiting
Contact: Somkit Penpattanagul, MD - 66-86-0442177 - skpptng@yahoo.co.th
Start Date
January 2014
Completion Date
January 2017
Sponsors
Siriwan Tangjitgamol, MD
Source
Navamindradhiraj University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page