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IRCT20210808052110N1 IRCT 2021-10-21 Shiraz University of Medical Sciences To evaluate Neoadjuvant chemotherapy in treatment of unresectable cervical cancer patients To evaluate Neoadjuvant chemotherapy followed by chemoradiation in patients with unresectable cervical cancer 2021-10-23 anticipated 74 Complete https://irct.ir/trial/58000 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 cancer of cervix. Intervention group:Recieving 4 course chemotherapy with carboplatin (Area under curve ;AUC:5)and paclitaxel (175mg per square meter)every three week before chemoradiation with External beam radiation and brachytherapy up to 80 to 90Gy to high risk Clinical target volume (CTV)with prescribing concurrent cisplatin weekly(40mg per square meter). Yes - There is a plan to make this available What will be shared: Individual data of study participants and all data can be shared after unrecognized them When: Access period starts 12 months after the results are published To whom: Researchers of university scientifc institutes Conditions: Any kind of analysis can be done on the delievered data after it is clarified and proved Where to obtain: Marzie Heidarpourfard,email adress:heidarpourfard@sums.ac.ir How to obtain: Please send me an email explaining your request for which part of the data you need and description of the analysisin question. If I see it is fit,the data will be emailed to you within a week Comments:
public Marzieh Heidarpourfard
4th floor-Yas building-15/2 alley-Namazi street-Sattarkan Blvd
Shiraz Iran (Islamic Republic of) 7184763955 +98 71 3648 8332 heidarpourfard@sums.ac.ir Shiraz University of Medical Sciences scientific Marzieh Heidarpourfard
4th floor-Yas building-15/2 alley-Namazi street-Sattarkan Blvd
Shiraz Iran (Islamic Republic of) 7184763955 +98 71 3648 8332 heidarpourfard@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 1.Unresectable cervical cancer(IIB toIVA,IB3,IIAmore than 4cm) 2.No history of metastasis 3.Adequate renal function(GFR more than 60ml per min per1.73) 4.Adequate hepatic function(Liver enzyme<5* upper limit normal) 5.Adequate bone marrow function(Absolute neutrophil>1500) 6-Without history of systemic disease 7.Absence of active infection 8.Absence of previous or concurrent oncology pathology 9.ECOG performance status 0 and 1 10.Age 18 to 75 years 18 years 75 years Female 1-Previous pelvic radiation 2-Pregnancy 3-Serious medical illness 4-Hypersensitivity to chemotherapy agent C53 Malignant neoplasm of cervix uteri Treatment - Drugs Intervention group:Recieving 4 course chemotherapy with carboplatin (Area under curve ;AUC:5)and paclitaxel (175mg per square meter)every three week before chemoradiation with External beam radiation and brachytherapy up to 80 to 90Gy to high risk Clinical target volume (CTV)with prescribing concurrent cisplatin weekly(40mg per square meter) Response to treatment 3 months after fulfilling it. Timepoint: 3 months after fulfilling treatment. Method of measurement: To do MRI and evaluate response to treatment by recist 1.1 guideline. Shiraz University of Medical Sciences Approved 2021-06-21 Ethics committee of Shiraz university of medicine Shiraz university of medicine-in front of Felestin street-Zand street-Shiraz Shiraz Fars Iran (Islamic Republic of)