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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Ruijin Hospital | OTHER |
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The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.
This is a multicenter, non-inferiority, phase 3, randomized controlled study. This study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to this experimental regimen versus the standard of treatment.The purpose of this study is to access safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with high-dose-rate brachytherapy in patients with cervical cancer, which based on the previous research (NCT05994300).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental |
|
| Control group | Active Comparator | Radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderated hypofractionated online adaptive radiotherapy | Combination Product | Radiation: Moderated hypofractionated online adaptive radiotherapy (oART)+ High-dose rate (HDR) Brachytherapy Experimental group: 43.35Gy/17F external beam radiotherapy with oART + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of tumor regression throughout EBRT | To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Zeng, MD. | Contact | 86-10-6512-4875 | zengzheng1206@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40671096 | Derived | Zeng Z, Chen Y, Qiu J, Yang B, Wang Z, Meng X, Sun Y, Yan J, Hu K, Zhang F. Moderately hypofractionated online adaptive radiotherapy (SWIFT-1) in cervical cancer patients: study protocol for a multi-centered, open-label, two-arm, phase III, randomized controlled study. Radiat Oncol. 2025 Jul 16;20(1):112. doi: 10.1186/s13014-025-02688-7. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Conventional radiotherapy | Combination Product | Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Contral group: 45Gy/25F EBRT + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors |
|
| 3 months |
| Late toxicity | Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up. | 3 years |
| Overall survival | Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first. | 3 years |
| Quality of life (QoL) | QoL will evaluated by the EORTC QLQ-C30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent." | 3 years |
| Quality of Life (QoL) | QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively. The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much). | 3 years |
| Locoregional progression-free survival | Defined as time from date of randomization to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first. | 3 years |
| Tumor response evaluation Complete remission rate | Evaluated with RECIST 1.1 | 3 months |
| Metastasis-free survival | Defined as time from date of randomization to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first. | 3 years |
| Cervical cancer-specific survival | Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first. | 3 years |
| Treatment expense | The treatment-related costs incurred during the course of treatment. | 3 months |
| 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 |