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IRCT20200617047815N1 IRCT 2020-08-22 Tehran University of Medical Sciences Comparison of treatment outcomes and complications of short-term and long-term brachytherapy in patients with cervical cancer acute and subacute complications of short course brachytherapy compared with conventional brachytherapy treatment in patients with cervical cancer after completion of external radiotherapy 2017-04-04 anticipated 66 Complete https://irct.ir/trial/49095 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Cervical Cancer. Intervention 1: Intervention group: We performed pelvic MRI for each patient to determine stage of cancer. Then according to three dimensional planing and physics calculation, study participants were treated with external chemoradiation (50 Gy in 25 fractions) with a linear accelerator. They also received weekly Cisplatin for 5 weeks.MRI was done immediately after completion of external chemoradiation . three high dose rate brachytherapy sessions by afterloading multi source device built by BEBIG company were administered every other day during 1 week for reducing overall treatment time.brachytherapy is a procedure that involves placing radioactive material(radium) inside the body(cervix).applicator selection depended on initial tumor and response rate to the external chemoradiation including tandem ovoid,tandem cylinder and tandem cylinder needle.if tandem ovoid did not covered sufficiently we used needle.We administrated dose of 85 to 90Gray to high risk clinical target volume and 70 to 75Gray to intermediate clinical target volume. Intervention 2: In control group We performed pelvic MRI for each patient to determine stage of cancer. Then according to three dimensional planing and physics calculation, study participants were treated with external chemoradiation (50 Gy in 20 fractions) with a linear accelerator. They also received weekly Cisplatin for 5 weeks.high dose rate brachytherapy by afterloading multi source device built by BEBIG company was given to patients over 3 weeks (1 session in each week).brachytherapy is a procedure that involves placing radioactive material(radium) inside the body(cervix).Applicator selection and insertion dose was selected based on response to external chemoradiation and baseline status of tumor including tandem ovoid,tandem cylinder and tandem cylinder needle.if tandem ovoid did not covered sufficiently we used needle. We administrated dose of 85 to 90Gray to high risk clinical target volume and 70 to 75Gray to intermediate clinical target volume. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Maryam Garousi
Department of Radiation oncology ,Iran University of Medical sciences,Hemat highway,Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2288 4548 garousi.m@iums.ac.ir Iran University of Medical Sciences scientific Maryam Garousi
department of radio oncology،Iran University of medical sciences ,Hemat highway,Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2288 4548 garousi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) age less than 70 years old histopathology Adenocarcinoma & squamous cell carcinoma suitable performance status Stage 1b-4a hemoglobin more than 10 Cervical cancer patients Females 20 years 70 years Female Recurrent disease other treatment procedure like surgery C53 Malignant neoplasm of cervix uteri Treatment - Other Treatment - Other Intervention group: We performed pelvic MRI for each patient to determine stage of cancer. Then according to three dimensional planing and physics calculation, study participants were treated with external chemoradiation (50 Gy in 25 fractions) with a linear accelerator. They also received weekly Cisplatin for 5 weeks.MRI was done immediately after completion of external chemoradiation . three high dose rate brachytherapy sessions by afterloading multi source device built by BEBIG company were administered every other day during 1 week for reducing overall treatment time.brachytherapy is a procedure that involves placing radioactive material(radium) inside the body(cervix).applicator selection depended on initial tumor and response rate to the external chemoradiation including tandem ovoid,tandem cylinder and tandem cylinder needle.if tandem ovoid did not covered sufficiently we used needle.We administrated dose of 85 to 90Gray to high risk clinical target volume and 70 to 75Gray to intermediate clinical target volume. In control group We performed pelvic MRI for each patient to determine stage of cancer. Then according to three dimensional planing and physics calculation, study participants were treated with external chemoradiation (50 Gy in 20 fractions) with a linear accelerator. They also received weekly Cisplatin for 5 weeks.high dose rate brachytherapy by afterloading multi source device built by BEBIG company was given to patients over 3 weeks (1 session in each week).brachytherapy is a procedure that involves placing radioactive material(radium) inside the body(cervix).Applicator selection and insertion dose was selected based on response to external chemoradiation and baseline status of tumor including tandem ovoid,tandem cylinder and tandem cylinder needle.if tandem ovoid did not covered sufficiently we used needle. We administrated dose of 85 to 90Gray to high risk clinical target volume and 70 to 75Gray to intermediate clinical target volume. The rate of cystitis based on common terminology criteria for adverse events. Timepoint: assess the symptoms before brachytherapy, 0- 30 - 90 days after treatment. Method of measurement: Side effects were recorded by radiation oncologist using the Common terminology criteria for adverse events(CTCAE) guideline. The rate of proctitis based on common terminology criteria for adverse events. Timepoint: assess the symptoms before brachytherapy, 0- 30 - 90 days after treatment. Method of measurement: Side effects were recorded by radiation oncologist using the Common terminology criteria for adverse events(CTCAE) guideline. The rate of vaginitis based on common terminology criteria for adverse events. Timepoint: assess the symptoms before brachytherapy, 0- 30 - 90 days after treatment. Method of measurement: Side effects were recorded by radiation oncologist using the Common terminology criteria for adverse events(CTCAE) guideline. Tehran University of Medical Sciences Approved 2018-07-22 Ethics committee of Tehran university of Medical Sciences Tehran university of Medical Sciences;Poursina Street,Tehran , Tehran Province, Tehran Tehran Iran (Islamic Republic of)