Proton and Carbon Ion Radiotherapy for Cervical Cancer | NCT05141825

Studies
Proton and Carbon Ion Radiotherapy for Cervical Cancer

NCT05141825

Sponsor

Shanghai Proton and Heavy Ion Center

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Cervical Cancer

Interventions

proton and carbon ion radiotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Oct 31, 2021Actual

Completion Date

Oct 31, 2021Actual

First Submitted Date

Nov 23, 2021

First Submission Date that Met QC Criteria

Nov 30, 2021

First Posted Date

Dec 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2021

Last Update Posted Date

Dec 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhan Yu, physician of abdorminal and pelvic oncology department, Shanghai Proton and Heavy Ion CenterPrincipal Investigator

Lead Sponsor

Shanghai Proton and Heavy Ion CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
proton and carbon ion radiotherapy	Experimental	proton and carbon ion radiotherapy	Radiation: proton and carbon ion radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
proton and carbon ion radiotherapy	Radiation	proton and carbon ion radiotherapy	proton and carbon ion radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival rate	overall survival rate	3 years
local control rate	local control rate	3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qing Zhang, MD	Shanghai Proton and Heavy Ion Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011522	Protons
D063193	Heavy Ion Radiotherapy

Ancestor Terms

ID	Term
D002414	Cations, Monovalent
D002412	Cations
D007477	Ions
D004573	Electrolytes
D007287

Browse Leaves

Not provided

Browse Branches

Not provided