Status:
RECRUITING
Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Cervix Uteri Cancer
Eligibility:
FEMALE
18-85 years
Phase:
PHASE2
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 short...
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 c...
Eligibility Criteria
Inclusion
- Pathology of squamous cell carcinoma (SCC), adenocarcinoma, adenosquamous carcinoma of uterine cervix- International Federation of Gynecology and Obstetrics (FIGO) stage IB, IIA, IIB, IIIA, IIIB (due to hydronephrosis without creatinine clearance compromise), IIIC1 (if less than 3 lymph nodes with size less than 3cm, and without involvement of common iliac chain)- Patient eligible for definitive chemoradiotherapy followed by brachytherapy
Exclusion
- Creatinine clearance less than 30ml/min, any histology other than the above, requirement of paraaortic lymph node irradiation, inflammatory bowel disease, connective tissue disorders, previous pelvic radiotherapy, FIGO stage IA or IV, Eastern Cooperative Oncology Group (ECOG) performance status greater than 2, History of previous hysterectomy
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04831437
Start Date
April 1 2021
End Date
March 1 2028
Last Update
October 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Imam Khomeini Hospital Complex
Tehran, Iran, 1419733141