NCT04831437

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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 radiotherapy(EBRT) to a total dose of 40 Gy in 15 fractions within 3 weeks concurrently with weekly chemotherapy with cisplatin 40mg/m2 (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 40mg/m2 (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 5.0 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.

Conditions

• Cervix Uteri Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated EBRT	EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2
RADIATION	Standard EBRT	EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-03-01
• Completion: 2028-03-01
• First posted: 2021-04-05
• Last updated: 2021-10-12

Locations

1 site across 1 country: Iran