Stereotactic Body Radiotherapy for Oligometastases From C... | NCT02909114

Studies
Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

NCT02909114

Sponsor

Jing Jin, M.D.

Status

Unknown status

Last Update Posted

Sep 21, 2016Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

Stereotactic body radiotherapy

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

Sep 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

Jan 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 21, 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

Sep 20, 2016

Last Update Posted Date

Sep 21, 2016Estimated

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

Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer

Detailed Description

Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	SBRT for oligometastatases from colorectal cancer objectives	Radiation: Stereotactic body radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stereotactic body radiotherapy	Radiation	All patients will undergo planning CT simulation. 4-dimensional CT will be used for tumors in the lungs or liver. For all lesions, the gross tumor volume (GTV) will be defined as the visible tumor on CT and/or MRI imaging +/- PET. A Planning Target Volume (PTV) margin of 3-5 mm will be added depending on site of disease, immobilization, and institutional set-up accuracy. The prescirbe dosage was as following: Lung lesion DT50-60 Gy/5 fractions; liver 50-60Gy/5-8 fractions; brain DT 40Gy/4-5fractions. All will be treated with SBRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
local control assessed by RECIST		3 years

Secondary Outcomes

Measure	Description	Time Frame
>= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0		from radiotherapy start to complete treatment 90 days
overall survival		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-75 years
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
Diagnosis by pathological examination
Primary lesion is under control by surgery
Adequate blood counts:
- White blood cell count ≥3.5 x 109/L
- Haemoglobin levels ≥100g/L
- Platelet count ≥100 x 109/L
- Creatinine levels ≤1.0× upper normal limit (UNL)
- Urea nitrogen levels ≤1.0× upper normal limit (UNL)
- Alanine aminotransferase (ALT) ≤1.5× upper normal limit (UNL)
- Aspartate aminotransferase (AST) ≤1.5× upper normal limit (UNL)
- Alkaline phosphatase (ALP) ≤1.5× upper normal limit (UNL)
- Total bilirubin (TBIL) ≤1.5× upper normal limit (UNL)

Exclusion Criteria:

Primary lesion is not under control
Pancreatic carcinoma
Oligometastases could not be located
Pregnancy or breast feeding
Symptoms or history of peripheral neuropathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ning Li, Doctor	Contact	13810381399	+86	lee_ak@163.com
Jing Jin, Doctor	Contact	13601365130	+86	jingjin1025@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital Chinese Acadamy of Medical Sciences	Recruiting	Beijing	Beijing Municipality	10021	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016634	Radiosurgery

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided