Individualized Precise Radiotherapy With the Guidance of Radiosensitivity of Locally Advanced Cervical Cancer
PROGRAMMA
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedMay 23, 2017
May 1, 2017
3.8 years
April 17, 2017
May 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
Progression-Free-Survival
3 years
Secondary Outcomes (2)
OS
3 years
TTP
3years
Study Arms (4)
PET/CT and Comet assay guided IMRT
ACTIVE COMPARATOR18F-FDG PET/CT and Comet assay guide IMRT Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.
PET/CT and Comet assay guided RapidArc
ACTIVE COMPARATOR18F-FDG PET/CT and Comet assay guide RapidArc: 1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.
RapidArc
ACTIVE COMPARATORRapidArc: A maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360° coplanar arcs (one clockwise arc rotated from 181° to 179° and the other counter-clockwise arc rotated from 179° to 181°) sharing the same isocentre were used.
7f-IMRT
SHAM COMPARATORseventy-five patients received IMRT. The 7f-IMRT gantry angles were 0°, 51°, 102°, 153°, 204°, 255° and 306°, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons.
Interventions
1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.
Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.
RapidArc: A maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360° coplanar arcs (one clockwise arc rotated from 181° to 179° and the other counter-clockwise arc rotated from 179° to 181°) sharing the same isocentre were used.
seventy-five patients received IMRT. The 7f-IMRT gantry angles were 0°, 51°, 102°, 153°, 204°, 255° and 306°, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons.
Eligibility Criteria
You may qualify if:
- Age : 18-70 years old;
- Histology or cytology confirmed cervical squamous cell carcinomas;
- FIGO stage includesⅠB2, ⅡA2, ⅡB-ⅣA;
- Performance status(PS): 0-1;
- 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;
- 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;
- Signed informed consent before treatment.
You may not qualify if:
- There is no definite pathological diagnosis;
- Clinical or imaging examination revealed distant metastases;
- Pelvic had received radiotherapy;
- Patients can't attend the study because of the associated with other diseases;
- Patients can't sign the informed consent because of mental disorders, mental disorders;
- Uncontrolled active infection;
- No follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Medical University Affiliated Suzhou Hospital
Suzhou, Jiangsu, 215000, China
Related Publications (1)
Ji S, Hu Q, Zhu J, Chen J, Chen Q, Liu Z, Shen C, Yang R, Sun H, Wu J, Gu K. Combined pretreatment with 18F-FDG PET/CT and Comet assay guides the concurrent chemoradiotherapy of locally advanced cervical cancer: study protocol for a randomized controlled trial. Trials. 2018 Aug 3;19(1):416. doi: 10.1186/s13063-018-2800-7.
PMID: 30075736DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhi-liang Ding
Health and Family Planning Commission of Jiangsu Province, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
April 17, 2017
First Posted
May 23, 2017
Study Start
July 1, 2015
Primary Completion
April 30, 2019
Study Completion
July 31, 2019
Last Updated
May 23, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share