Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Neoplasms

Uterine Cervical Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

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

Hypofractionated EBRT

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

Standard EBRT

Kasra Kolahdouzan, M.D.

Ebrahim Esmati, M.D.

Afsaneh Maddah-Safaei, M.D.

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.

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.

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

Early treatment-related toxicity within 3 months after completion of treatment as defined by CTCAE 5.0.

Early response to treatment at 3 months after treatment completion based on dynamic contrast-enhanced pelvic MRI findings

Late treatment-related toxicity within 1 and 3 years after completion of treatment as defined by CTCAE 5.0.

Time from randomization to progression(based on MRI and physical examination), death, or last follow up; whichever that occurs first

Time from randomization to death from cervical cancer or last follow-up; whichever that occurs first.

Time from randomization to death from any reason or last follow-up; whichever that occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer	NCT04831437	Cervix Uteri Ca...	Hypofractionate... Standard EBRT	18 Years - 85 Years	Tehran University of Medical Sciences
Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer	NCT04831437	Cervix Uteri Ca...	Hypofractionate... Standard EBRT	18 Years - 85 Years	Tehran University of Medical Sciences

Spots Global Cancer Trial Database for hypofractionated ebrt