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External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17 fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy | Radiation | Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy Drug: Concurrent Chemotherapy Weekly cisplatin 40 mg/m2 |
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity | Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up. | 3 years |
| Response evaluation evaluated with RECIST 1.1 | Evaluated with RECIST 1.1 |
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Inclusion Criteria:
Age 18 years to 70 years
FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers
FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain
Histology: squamous
Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
Brachytherapy candidate
Functional State Eastern Cooperative Oncology Group (ECOG)0-2
Exclusion Criteria:
Patients who had chemotherapeutic, surgical and/or radiotherapy treatment
FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes
Previous pelvic or abdominal radiotherapy
Patient unable to undergo MR scan
ECOG performance status greater than 2
Not a cisplatin candidate
Other factors that contraindicate experimental therapy
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| Name | Affiliation | Role |
|---|---|---|
| Fuquan Zhang, MD | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100010 | China |
To protect the privacy of the patients
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| One month after treatment |
| Disease-free survival | Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up. | 3 years |
| Overall survival | Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up. | 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. | 3 years |
| Quality of life (QoL) | QoL will evaluated by the EORTC QLQ-C-30 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 |
| 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 |
| 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 |
| D014947 | Wounds and Injuries |