Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer

Conditions
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Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect

Intervention / Treatment
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* Radiation: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderately Hypofractionated Adaptive Radiotherapy<br> | Radiation: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy<br>* Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy Drug: Concurrent Chemotherapy Weekly cisplatin 40 mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The scores can then be added to come up with an overall quality of life score. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderately hypofractionated radiotherapy, adaptive radiotherapy, cervical cancer.