Carbon Ion Radiotherapy in Treating Patients Undergoing S... | NCT02935023

Studies
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

NCT02935023

Sponsor

Shanghai Proton and Heavy Ion Center

Status

Unknown status

Last Update Posted

Oct 17, 2016Estimated

Enrollment

47Estimated

Phase

Phase 2

Conditions

Metastatic Prostate Carcinoma

Interventions

CIRT with systemic therapy arm

Countries

China

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Oct 11, 2016

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 17, 2016Estimated

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

Oct 13, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shen Fu, Director,department of radiation oncology, 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

Not provided

Is FDA Regulated Device

Not provided

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 goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CIRT with systemic therapy arm	Experimental	Carbon ion radiotherapy combined with systemic therapy	Radiation: CIRT with systemic therapy arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CIRT with systemic therapy arm	Radiation	carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to PSA relapse		From the start of systemic therapy, a median of 2 years

Secondary Outcomes

Measure	Description	Time Frame
progression free survival		From the start of systemic therapy, a median of 2 years
Overall survival		From the start of systemic therapy, a median of 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed adenocarcinoma of the prostate
Age ≥ 20 and < 80 years of age
ECOG PS 0 or 1
Life-expectancy ≥1 year
Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
Ability to understand and willingness to sign informed consent

Exclusion Criteria:

No pathologically confirmed adenocarcinoma of the prostate
visceral metastasis
Previous pelvic radiotherapy or prostatectomy
Severe systemic disorders

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ping Li, MD.	Contact	+86 02138296666		ping.li@sphic.org.cn
Qing Zhang, MD.	Contact	+86 02138296666		qing.zhang@sphic.org.cn

Overall Officials

Name	Affiliation	Role
Shen Fu, PhD.MD.	Shanghai Proton and Heavy Ion Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Proton and Heavy Ion Center	Recruiting	Shanghai	Shanghai Municipality	201321	China

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
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063193	Heavy Ion Radiotherapy

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided