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

Cervix Uteri Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831437
• Other study ID #: 9711880002
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: March 2028

Study information

• Verified date: March 2021
• Source: Tehran University of Medical Sciences
• Contact: Kasra Kolahdouzan, M.D.
• Phone: +989144083785
• Email: k-kolahdouzan[@]razi.tums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2028
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cervix Uteri Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Radiation:
• Hypofractionated EBRT
EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2
• Standard EBRT
EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital Complex	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early toxicity	Early treatment-related toxicity within 3 months after completion of treatment as defined by CTCAE 5.0.	3 months after completion of treatment
Primary	Early response	Early response to treatment at 3 months after treatment completion based on dynamic contrast-enhanced pelvic MRI findings	3 months after completion of treatment
Secondary	Late toxicity	Late treatment-related toxicity within 1 and 3 years after completion of treatment as defined by CTCAE 5.0.	1 and 3 years after completion of treatment
Secondary	Progression-free survival	Time from randomization to progression(based on MRI and physical examination), death, or last follow up; whichever that occurs first	5 years
Secondary	Disease-specific survival	Time from randomization to death from cervical cancer or last follow-up; whichever that occurs first.	5 years
Secondary	Overall survival	Time from randomization to death from any reason or last follow-up; whichever that occurs first.	5 years