Adjuvant Chemotherapy for Locally Advanced Cervical Cancer
NCT ID: NCT02036164
Last Updated: 2017-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2014-01-31
2019-01-31
Brief Summary
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Detailed Description
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This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Concurrent chemoradiation
Radiation: Radiation Therapy
* External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
* Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin
\- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
Pelvic radiation
Radiation:
* Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
* Brachytherapy 30-35 Gy for 4-5 times
Cisplatin
Cisplatin 40 mg/m2 i.v.
Concurretn chemoradiation plus adjuvant chemotherapy
Radiation: Radiation Therapy
* External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
* Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin, paclitaxel, carboplatin
* Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
* Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT
* Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
Pelvic radiation
Radiation:
* Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
* Brachytherapy 30-35 Gy for 4-5 times
Cisplatin
Cisplatin 40 mg/m2 i.v.
Paclitaxel
Paclitaxel 175 mg m2 i.v.
Carboplatin
Carboplatin AUC 5 i.v.
Interventions
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Pelvic radiation
Radiation:
* Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
* Brachytherapy 30-35 Gy for 4-5 times
Cisplatin
Cisplatin 40 mg/m2 i.v.
Paclitaxel
Paclitaxel 175 mg m2 i.v.
Carboplatin
Carboplatin AUC 5 i.v.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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National Research Council of Thailand
OTHER_GOV
Navamindradhiraj University
OTHER
Chiang Mai University
OTHER
Prince of Songkla University
OTHER
Bhumibol Adulyadej Hospital
OTHER
Lopburi Cancer Hospital
UNKNOWN
Ubonratchathani Cancer Hospital
UNKNOWN
Udonthani Cancer Hospital
UNKNOWN
Chonburi Cancer Hospital
UNKNOWN
Lampang Cancer Hospital
OTHER
Health Intervention and Technology Assessment Program
UNKNOWN
Rajburi Hospital
UNKNOWN
Siriwan Tangjitgamol, MD
OTHER
Responsible Party
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Siriwan Tangjitgamol, MD
Doctor
Principal Investigators
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Siriwan Tangjitgamol, MD
Role: PRINCIPAL_INVESTIGATOR
Navamindradhiraj University
Vichan Lordvithaya, MD
Role: PRINCIPAL_INVESTIGATOR
Chiang Mai University
Locations
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Bhumibol Adulyadej Hospital
Bangkok, Bangkok, Thailand
Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University
Bangkok, Bangkok, Thailand
Health Intervention and Technology Assessment Program
Bangkok, Bangkok, Thailand
Chonburi Cancer Hospital
Chon Buri, Changwat Chon Buri, Thailand
Lampang Cancer Hospital
Lampang, Changwat Lampang, Thailand
Lopburi Cancer Hospital
Lopburi, Changwat Lop Buri, Thailand
Ratchaburi Hospital
Muang, Changwat Ratchaburi, Thailand
Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University
Songkhla, Changwat Songkhla, Thailand
Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University
Chiang Mai, Chiang Mai, Thailand
Ubonratchathani Cancer Hospital
Ubonratchathani, Ubonratchathani, Thailand
Udonthani Cancer Hopital
Udon Thani, Udonthani, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Tangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. doi: 10.3802/jgo.2019.30.e82. Epub 2019 Apr 10.
Other Identifiers
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20140106001
Identifier Type: REGISTRY
Identifier Source: secondary_id
COA-CREC 002/2013
Identifier Type: -
Identifier Source: org_study_id
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