RecruitingPhase 2NCT04831437

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

Comparison of Clinical Response and Toxicity of Hypo-fractionated Chemoradiation With Standard Treatment in Patients With Uterine Cervix Cancer


Sponsor

Tehran University of Medical Sciences

Enrollment

60 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a shorter, more intense course of radiation (called hypofractionated chemoradiotherapy) works just as well as a longer standard course for treating cervical cancer. Fewer sessions could be more convenient and equally effective for patients. **You may be eligible if...** - You have been diagnosed with cervical cancer confirmed by pathology (squamous cell carcinoma, adenocarcinoma, or adenosquamous type) - Your cancer is at a stage eligible for definitive treatment with radiation and chemotherapy (FIGO stages IB–IIIC1 with certain conditions) - You are planned to receive chemoradiotherapy followed by brachytherapy (internal radiation) - Your kidneys function well enough to tolerate chemotherapy **You may NOT be eligible if...** - Your cancer is at a very early stage (IA) or has spread very far (stage IV) - Your kidneys are not functioning well enough (creatinine clearance below 30 ml/min) - You have inflammatory bowel disease or connective tissue disorders - You have had prior radiation to the pelvis - Your ECOG performance score is above 2 (meaning you are bedridden or too unwell) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated EBRT

EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2

RADIATIONStandard EBRT

EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2


Locations(1)

Imam Khomeini Hospital Complex

Tehran, Iran

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NCT04831437