Adaptive Radiotherapy, Cervical Neoplasm, Radiotherapy; Adverse Effect
Conditions
Keywords
moderately hypofractionated radiotherapy, adaptive radiotherapy, cervical cancer.
Brief summary
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
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.
Interventions
RADIATIONModerately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy Drug: Concurrent Chemotherapy Weekly cisplatin 40 mg/m2
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response evaluation evaluated with RECIST 1.1 | One month after treatment | Evaluated with RECIST 1.1 |
| Disease-free survival | 3 years | 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. |
| Late toxicity | 3 years | Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up. |
| Quality of life (QoL) | 3 years | QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. |
| Assessment of tumor regression throughout EBRT | 3 months | To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans. |
| Overall survival | 3 years | Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up. |
Countries
China
Outcome results
None listed