Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831437
Status:
RECRUITING
Last Update Posted:
2021-10-12
First Post:
2021-04-02
Brief Title:
Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Comparison of Clinical Response and Toxicity of Hypo-fractionated Chemoradiation With Standard Treatment in Patients With Uterine Cervix Cancer
Status:
RECRUITING
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Uterine cervix cancer can be treated definitively with concurrent chemoradiation external beam radiotherapy and chemotherapy followed by high dose rate brachytherapy Treatment duration can be shortened by increasing the dose per fraction of treatment which can reduce costs and patient exposure The aim of our study is to determine the non-inferiority of hypofractionated radiotherapy compared with conventional treatment
Detailed Description:
In this study we aim to determine if clinical response and toxicity of radiotherapy hypofractionation is non-inferior to the conventional treatment We will enroll 60 eligible patients with cervical cancer stage IB to IIIC and randomly allocate them into the intervention hypofractionation group or the control standard groups The patients in the intervention group will receive external beam radiotherapyEBRT to a total dose of 40 Gy in 15 fractions within 3 weeks concurrently with weekly chemotherapy with cisplatin 40mgm2 total of 3 cycles Whereas the control group will receive EBRT to a total dose of 45 Gy in 25 fractions within 5 weeks concurrently with weekly chemotherapy with cisplatin 40mgm2 total of 5 cycles All patients from both groups will undergo high dose rate brachytherapy one week after completion of EBRT to a total dose of 28 Gy per 4 weekly sessions Patients will be evaluated regarding early and late toxicities as described by Common Terminology Criteria for Adverse Events CTCAE version 50 at the completion of brachytherapy and at 3 months 6 months and 3 years from completion of treatment Also clinical response will be evaluated through dynamic contrast enhanced pelvic MRI 3 months 1 year and 3 years after completion of brachytherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None