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

Phase 2

Recruiting

• Conditions: Cervix Uteri Cancer
• Interventions: Radiation: Hypofractionated EBRT; Radiation: Standard EBRT

• Registration Number: NCT04831437
• Lead Sponsor: Tehran University of Medical Sciences

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 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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-04-01
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12
• Primary Completion: 2023-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated	Hypofractionated EBRT	EBRT 40Gy/15fr
Control Group	Standard EBRT	EBRT 45Gy/ 25fr

Primary Outcome Measures

Name	Time	Method
Early toxicity	3 months after completion of treatment	Early treatment-related toxicity within 3 months after completion of treatment as defined by CTCAE 5.0.
Early response	3 months after completion of treatment	Early response to treatment at 3 months after treatment completion based on dynamic contrast-enhanced pelvic MRI findings

Secondary Outcome Measures

Name	Time	Method
Late toxicity	1 and 3 years after completion of treatment	Late treatment-related toxicity within 1 and 3 years after completion of treatment as defined by CTCAE 5.0.
Progression-free survival	5 years	Time from randomization to progression(based on MRI and physical examination), death, or last follow up; whichever that occurs first
Disease-specific survival	5 years	Time from randomization to death from cervical cancer or last follow-up; whichever that occurs first.
Overall survival	5 years	Time from randomization to death from any reason or last follow-up; whichever that occurs first.

Trial Locations

Locations (1)

Imam Khomeini Hospital Complex; 🇮🇷 Tehran, Iran, Islamic Republic of