Cervix Uteri Cancer
Conditions
Keywords
Hypofractionation, Chemoradiation, Brachytherapy
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.
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
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Iran
Contacts
Primary ContactKasra Kolahdouzan, M.D.
Backup ContactEbrahim Esmati, M.D.
Outcome results
None listed