Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated | Experimental | EBRT 40Gy/15fr |
|
| Control Group | Active Comparator | EBRT 45Gy/ 25fr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated EBRT | Radiation | EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Progression-free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kasra Kolahdouzan, M.D. | Contact | +989144083785 | k-kolahdouzan@razi.tums.ac.ir | |
| Ebrahim Esmati, M.D. | Contact | +989126880306 | eb_esmati@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Afsaneh Maddah-Safaei, M.D. | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Khomeini Hospital Complex | Recruiting | Tehran | 1419733141 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38244105 | Derived | Maddah Safaei A, Esmati E, Gomar M, Akhavan S, Sheikh Hasani S, Malekzadeh Moghani M, Zamani N, Moshtaghi M, Malek M, Jafari F, Sharifian A, Kolahdouzan K. Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial. J Cancer Res Clin Oncol. 2024 Jan 20;150(1):20. doi: 10.1007/s00432-023-05563-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard EBRT | Radiation | EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2 |
|
Time from randomization to progression(based on MRI and physical examination), death, or last follow up; whichever that occurs first
| 5 years |
| Disease-specific survival | Time from randomization to death from cervical cancer or last follow-up; whichever that occurs first. | 5 years |
| Overall survival | Time from randomization to death from any reason or last follow-up; whichever that occurs first. | 5 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |