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The purpose of this phase II study is to determine the survival free disease of patients diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive chemoradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo-induction | Experimental | Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy |
|
| Chemoradiotherapy | Active Comparator | Cisplatin, radiotherapy and brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 50 mg/m2 - Day 1 |
| |
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | From the randomization until the end of the treatment - up to 36 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 36 month after the end of the treatment. | |
| Locoregional disease control rate | 36 month after the end of treatment. | |
| Acute and chronic toxicity in both arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Del Pilar Estevez Diz, MD | Contact | 55 11 3893-2000 | pesquisa.clinica@icesp.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Maria Del Pilar Estevez Diz, MD | Instituto do Cancer do Estado de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICESP | Recruiting | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32321767 | Derived | Nunes de Arruda F, da Costa S, Bonadio R, Dornellas A, Pereira D, de Bock GH, Del Pilar Estevez Diz M. Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial. Int J Gynecol Cancer. 2020 Jun;30(6):749-756. doi: 10.1136/ijgc-2019-001134. Epub 2020 Apr 21. | |
| 31449470 |
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| Drug |
Gemcitabine 1000mg/m2 on day 1 and day 8. |
|
| cisplatin | Drug | Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period. |
|
| Radiotherapy | Radiation | 45 Gy |
|
| Brachytherapy | Radiation | 80 Gy |
|
| From the randomization until the end of the treatment. |
| Overall survival | 36 month after the end of the treatment. |
| Derived |
| da Costa SCS, Bonadio RC, Gabrielli FCG, Aranha AS, Dias Genta MLN, Miranda VC, de Freitas D, Abdo Filho E, Ferreira PAO, Machado KK, Scaranti M, Carvalho HA, Estevez-Diz MDP. Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation Versus Chemoradiation for Locally Advanced Cervical Cancer: A Randomized Phase II Trial. J Clin Oncol. 2019 Nov 20;37(33):3124-3131. doi: 10.1200/JCO.19.00674. Epub 2019 Aug 26. |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
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