Back to resultsProton and Carbon Ion Radiotherapy for Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
proton and carbon ion radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring proton and carbon ion radiotherapy
Eligibility Criteria
Inclusion Criteria:
- . histologically diagnosis of squamous cell carcinoma of the cervix;
- . International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases;
- . received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
- . Follow-up data available.
Exclusion Criteria:
- a previous history of other malignancy;
- squamous cell carcinoma of the cervix patients who had received surgery;
- rectum was invaded.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
proton and carbon ion radiotherapy
Arm Description
proton and carbon ion radiotherapy
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
overall survival rate
overall survival rate
local control rate
local control rate
progression-free survival
progression-free survival
distant metastasis-free survival
distant metastasis-free survival
Full Information
NCT ID
NCT05141825
First Posted
November 23, 2021
Last Updated
November 30, 2021
Sponsor
Shanghai Proton and Heavy Ion Center
1. Study Identification
Unique Protocol Identification Number
NCT05141825
Brief Title
Proton and Carbon Ion Radiotherapy for Cervical Cancer
Official Title
Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer.
Detailed Description
To retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. The acute and late toxicities, overall survival (OS), local control rate (LC), progression-free survival (PFS) and distant metastasis-free survival (DMFS) were analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
proton and carbon ion radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
proton and carbon ion radiotherapy
Arm Type
Experimental
Arm Description
proton and carbon ion radiotherapy
Intervention Type
Radiation
Intervention Name(s)
proton and carbon ion radiotherapy
Intervention Description
proton and carbon ion radiotherapy
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
overall survival rate
Description
overall survival rate
Time Frame
3 years
Title
local control rate
Description
local control rate
Time Frame
3 years
Title
progression-free survival
Description
progression-free survival
Time Frame
3 years
Title
distant metastasis-free survival
Description
distant metastasis-free survival
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. histologically diagnosis of squamous cell carcinoma of the cervix;
. International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases;
. received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
. Follow-up data available.
Exclusion Criteria:
a previous history of other malignancy;
squamous cell carcinoma of the cervix patients who had received surgery;
rectum was invaded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Zhang, MD
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Proton and Carbon Ion Radiotherapy for Cervical Cancer
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