Individualized Precise Radiotherapy With the Guidance of Radiosensitivity of Locally Advanced Cervical Cancer

Phase 2

• Conditions: Cervical Cancer

• Registration Number: NCT03163979
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2017-04-17
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-21
• Last Update Submitted: 2017-05-21
• Study First Posted: 2017-05-23
• Last Update Posted: 2017-05-23
• Primary Completion: 2019-04-30
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Age : 18-70 years old;
2. Histology or cytology confirmed cervical squamous cell carcinomas;
3. 2009 FIGO stage includesⅠB2, ⅡA2, ⅡB-ⅣA;
4. Performance status(PS): 0-1;
5. Peripheral blood meet the following conditions: neutrophil count > 2.0 * 109/L, white blood cell count > 4.0 * 109/L, the platelet count > 100.0 * 109/L;
6. Liver and kidney function meet the following conditions: bilirubin < 1.5 mg/dl, AST and ALT < 2 times the upper limit of normal serum creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min;
7. Signed informed consent before treatment.

Exclusion Criteria

1. There is no definite pathological diagnosis;
2. Clinical or imaging examination revealed distant metastases;
3. Pelvic had received radiotherapy;
4. Patients can't attend the study because of the associated with other diseases;
5. Patients can't sign the informed consent because of mental disorders, mental disorders;
6. Uncontrolled active infection;
7. No follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PFS	3 years	Progression-Free-Survival

Secondary Outcome Measures

Name	Time	Method
OS	3 years	Overall survival
TTP	3years	Time to progression

Trial Locations

Locations (1)

Nanjing Medical University Affiliated Suzhou Hospital; 🇨🇳 Suzhou, Jiangsu, China