Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer

Recruiting now · Phase 2

Conditions studied: Cervix Uteri Cancer

In brief

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.

Key facts

Study ID

NCT04831437

Run by

Tehran University of Medical Sciences

People needed

60

Starts

2021-04-01

Expected to finish

2028-03-01

Last updated by the study team

2021-10-12

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Imam Khomeini Hospital Complex — Tehran, Iran (enrolling)

Full record on ClinicalTrials.gov

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