Cervical Cancer Clinical Trial
Official title:
Individualized Precise Radiotherapy With the Guidance of Radiosensitivity: A Study on the Clinical Management Model of Locally Advanced Cervical Cancer
Cisplatin-based chemoradiation (CCRT) has been considered as the standard care for patients
with locally advanced cervical cancer (LACC). Nevertheless, increasingly more
radio-resistant tumors still recur. IMRT including Rapid-Arc have obvious advantage in the
dose distribution and organ protection, and positron emission tomography (PET) with F-18
fluorodeoxyglucose (FDG) and Comet analysis have good sensitivity for detecting sites and
radiosensitivity of disease. These may be helpful to individualized CCRT of LACC.
Three hundred LACC patients are enrolled in the study, who were with FIGO stages IB2-IVA and
had no para-aortic lymphadenopathy (>10 mm) assessed by PET-CT or MRI. All the patients
received definitive radiotherapy consisting of external beam whole pelvic RT and HDR-ICBT.
The cumulative linear quadratic equivalent dose (EQD2) was 70-75Gy prescribed at point A.
Cisplatin 30 mg/m2 weekly was administered concurrently for 5 courses. 2-4 cycles TP (Taxol
135 mg/m2, D1 and DDP 25 mg/m2, D1-3) regimen sequential chemotherapy were performed if
complete response (CR) not achieved according to magnetic resonance imaging (MRI) or PET-CT
after CCRT. Hypothesis of the study is that CCRT and sequential chemotherapy is safe. Based
on FDG-PET/CT and Comet assay, higher doses can be safely delivered individually to accurate
tumor volume, while the doses to bladder and rectum are relative low. Comet and
FDG-PET/CT-guided IMRT including RapidArc may improve survival in terms of time to
progression (TTP), progression-free survival (PFS) and overall survival (OS) and less
treatment-related toxicity. The data will be observed and analyzed.
Cisplatin-based chemoradiation (CCRT) has been considered as the standard care for patients
with locally advanced cervical cancer (LACC). Nevertheless, increasingly more
radio-resistant tumors still recur. IMRT including Rapid-Arc have obvious advantage in the
dose distribution and organ protection, and positron emission tomography (PET) with F-18
fluorodeoxyglucose (FDG) and Comet analysis have good sensitivity for detecting sites and
radiosensitivity of disease. These may be helpful to individualized CCRT of LACC. IMRT
including RapidArc could be considered as a treatment selection for LACC patients, and it
aims to improve the degree of target coverage, to protect organ at risk (OARs) and healthy
tissue sparing compared to other RT solutions and to reduce significantly the treatment time
as to RapidArc. Several studies have indicated that FDG-PET/CT increases the accordance
between biopsies and delineated tumor volume and has the potential to positively impact the
course of treatment. The Comet assay is attractive as a potential clinical test of tumour
radiosensitivity. During radiotherapy, accurately defining disease areas is critical to
avoid unnecessary irradiation of normal tissue. Based on FDG-PET/CT and Comet assay, higher
doses can be safely delivered individually to accurate tumor volume, while the doses to
bladder and rectum are relative low.
Three hundred LACC patients are enrolled in the study, who were with FIGO stages IB2-IVA and
had no para-aortic lymphadenopathy (>10 mm) assessed by PET-CT or MRI. All the patients
received definitive radiotherapy consisting of external beam whole pelvic RT and HDR-ICBT.
The cumulative linear quadratic equivalent dose (EQD2) was 70-75Gy prescribed at point A.
Cisplatin 30 mg/m2 weekly was administered concurrently for 5 courses. 2-4 cycles TP (Taxol
135 mg/m2, D1 and DDP 25 mg/m2, D1-3) regimen sequential chemotherapy were performed if
complete response (CR) not achieved according to magnetic resonance imaging (MRI) or PET-CT
after CCRT. Hypothesis of the study is that CCRT and sequential chemotherapy is safe. Comet
and FDG-PET/CT-guided IMRT including RapidArc may improve survival in terms of time to
progression (TTP), progression-free survival (PFS) and overall survival (OS) and less
treatment-related toxicity. The data will be observed and analyzed.
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