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IRCT20211011052730N1 IRCT 2024-01-02 Shahid Beheshti University of Medical Sciences Comparison of chemotherapy before and after definitive chemotherapy-radiotherapy with definitive chemotherapy-radiotherapy alone in patients with advanced cervical cancer Comparative of neoadjuvant chemotherapy fallowed by definitive chemo-radiotherapy and adjuvant chemotherapy versus definitive chemoradiotherapy alone in locally advanced cervical cancer 2024-02-29 anticipated 35 Complete https://irct.ir/trial/59271 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Cancer of cervix. Intervention 1: Intervention group: One group will undergo a neoadjuvant protocol along with concomitant chemoradiotherapy. Initially, patients will receive four cycles of weekly carboplatin AUC=2 and paclitaxel 80mg/m2, followed by an evaluation with abdominopelvic diffusion MRI to assess the response rate. Patients showing a favorable response will continue chemotherapy for up to nine weekly cycles. Those who do not respond favorably will immediately commence definitive chemoradiotherapy with cisplatin 40mg/m2 concurrently with 40 to 45Gy EBRT and a 12 to 20Gy boost to the gross node if necessary. Based on indications, they will then receive 30Gy in 3 fractionations over 3 weeks of HDR brachytherapy. Individuals who respond to neoadjuvant chemotherapy will be treated with adjuvant six cycles of weekly carboplatin and paclitaxel. At the conclusion of all treatment stages, all patients will enter the follow-up phase and will be evaluated every three months by gynecologists and radiation oncologists. Intervention 2: Control group: The second group will undergo treatment with definitive chemoradiotherapy, including cisplatin 40mg/m2 concurrently with 40 to 45Gy EBRT and a 12 to 20Gy boost to the gross node if necessary. Based on indications, they will receive 30Gy in 3 fractions over 3 weeks of HDR brachytherapy alone. At the end of all treatment stages, patients will enter the follow-up phase and will be evaluated every three months by gynecologists and radiation oncologists. Yes - There is a plan to make this available What will be shared: Chemotherapy and radiotherapy protocol. Examinations and pathology and patient imaging When: After printing the results To whom: Researchers in scientific and academic institutions Conditions: Provide an official license from the relevant scientific and academic institution Where to obtain: shahrzad.ebrahimi1366@gmail.com How to obtain: Email to the address mentioned above and after confirmation and confirmation of the validity of the letter of introduction of the documents will be emailed to him/her Comments:
public Shahrzad Ebrahimi
Imam Hossein Hospita, lSouth Madani St.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 shahrzadebrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Robab Anbiaee
Imam Hossein Hospita, lSouth Madani St.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 anbiaee-mm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with advanced cervical cancer (FIGO Ib3-II-III-IVA) 20 years 80 years Female Previous treatment with neoadjuvant chemotherapy History of previous surgical treatment History of radiotherapy in the pelvis and abdomen C53.0 Malignant neoplasm of endocervix Treatment - Drugs Treatment - Drugs Intervention group: One group will undergo a neoadjuvant protocol along with concomitant chemoradiotherapy. Initially, patients will receive four cycles of weekly carboplatin AUC=2 and paclitaxel 80mg/m2, followed by an evaluation with abdominopelvic diffusion MRI to assess the response rate. Patients showing a favorable response will continue chemotherapy for up to nine weekly cycles. Those who do not respond favorably will immediately commence definitive chemoradiotherapy with cisplatin 40mg/m2 concurrently with 40 to 45Gy EBRT and a 12 to 20Gy boost to the gross node if necessary. Based on indications, they will then receive 30Gy in 3 fractionations over 3 weeks of HDR brachytherapy. Individuals who respond to neoadjuvant chemotherapy will be treated with adjuvant six cycles of weekly carboplatin and paclitaxel. At the conclusion of all treatment stages, all patients will enter the follow-up phase and will be evaluated every three months by gynecologists and radiation oncologists Control group: The second group will undergo treatment with definitive chemoradiotherapy, including cisplatin 40mg/m2 concurrently with 40 to 45Gy EBRT and a 12 to 20Gy boost to the gross node if necessary. Based on indications, they will receive 30Gy in 3 fractions over 3 weeks of HDR brachytherapy alone. At the end of all treatment stages, patients will enter the follow-up phase and will be evaluated every three months by gynecologists and radiation oncologists Disease free survival. Timepoint: One year and two year after intervention. Method of measurement: Physical exam and pelvic MRI. Improved treatment response. Timepoint: One year and two year after intervention. Method of measurement: Physical exam and pelvic MRI. Reduction of radiation therapy-related side effects. Timepoint: One year and two year after intervention. Method of measurement: History and Physical exam and pelvic MRI. Shahid Beheshti University of Medical Sciences Approved 2021-11-14 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Shahid Shahriari Square, Evin Tehran Tehran Iran (Islamic Republic of)