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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy Drug: Concurrent Chemotherapy Weekly cisplatin 40 mg/m2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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.
Time frame: 3 months
Late toxicity
Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Time frame: 3 years
Response evaluation evaluated with RECIST 1.1
Evaluated with RECIST 1.1
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 3 months
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