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| ID | Type | Description | Link |
|---|---|---|---|
| 20140106001 | Registry Identifier | TCTR |
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| Name | Class |
|---|---|
| National Research Council of Thailand | OTHER_GOV |
| Navamindradhiraj University | OTHER |
| Chiang Mai University | OTHER |
| Prince of Songkla University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent chemoradiation | Active Comparator | Radiation: Radiation Therapy
Chemotherapy: Cisplatin - Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy |
|
| Concurretn chemoradiation plus adjuvant chemotherapy | Experimental | Radiation: Radiation Therapy
Chemotherapy: Cisplatin, paclitaxel, carboplatin
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic radiation | Radiation | Radiation:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 3-year progression free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3-year overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response rate will be assessed at 4 months after completion of CCRT (expected to be at 4 months after CCRT in the control arm or at 1 month after completion of adjuvant chemotherapy in the study arm) | 4 months after completion of CCRT |
| Cost-utility analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siriwan Tangjitgamol, MD | Contact | 66-86-3841431 | siriwanonco@yahoo.com | |
| Vichan Lordvithaya, MD | Contact | 6681-6814367 | vilorvid@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Siriwan Tangjitgamol, MD | Navamindradhiraj University | Principal Investigator |
| Vichan Lordvithaya, MD | Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bhumibol Adulyadej Hospital | Recruiting | Bangkok | Bangkok | 10220 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31074236 | Derived | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D002945 | Cisplatin |
| D004364 | Pharmaceutical Preparations |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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 |
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|
| Cisplatin | Drug | Cisplatin 40 mg/m2 i.v. |
|
|
| Paclitaxel | Drug | Paclitaxel 175 mg m2 i.v. |
|
|
| Carboplatin | Drug | Carboplatin AUC 5 i.v. |
|
|
Cost and quality of life |
| Cost of treatment and quality of life will be assessed at baseline, completion of CCRT, q month for 3 months after CCRT, after each cycle of ACT, 2 years after completion of treatment, and when there are tumor persistence, progression or recurrence |
| Adverse event | Adverse events occurred during and after treatment | up to 6 months after treatment |
| Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University | Recruiting | Bangkok | Bangkok | 10300 | Thailand |
|
| Health Intervention and Technology Assessment Program | Not yet recruiting | Bangkok | Bangkok | 11000 | Thailand |
|
| Chonburi Cancer Hospital | Recruiting | Chon Buri | Changwat Chon Buri | 20000 | Thailand |
|
| Lampang Cancer Hospital | Recruiting | Lampang | Changwat Lampang | 52000 | Thailand |
|
| Lopburi Cancer Hospital | Recruiting | Lopburi | Changwat Lop Buri | 15000 | Thailand |
|
| Ratchaburi Hospital | Active, not recruiting | Muang | Changwat Ratchaburi | 70000 | Thailand |
| Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University | Recruiting | Songkhla | Changwat Songkhla | 90110 | Thailand |
|
| Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University | Recruiting | Chiang Mai | Chiang Mai | 50200 | Thailand |
|
| Ubonratchathani Cancer Hospital | Recruiting | Ubonratchathani | Ubonratchathani | 34000 | Thailand |
|
| Udonthani Cancer Hopital | Recruiting | Udon Thani | Udonthani | 41330 | Thailand |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |