Detection and Enumeration of Circulating Tumor Cells in R... | NCT01671891

Studies
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

NCT01671891

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Aug 24, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Rectal Cancer

Interventions

radiation therapy
capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)

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

Aug 2012

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

Feb 2012

Primary Completion Date

Not provided

Completion Date

Feb 2013Estimated

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Aug 21, 2012

First Posted Date

Aug 24, 2012Estimated

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

Aug 21, 2012

Last Update Posted Date

Aug 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhen Zhang, director of radiotherapy department in Fudan university shanghai cancer center, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

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

Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rectal cancer with stage II-IV		rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin	Radiation: radiation therapy Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiation therapy	Radiation	45-55Gy	rectal cancer with stage II-IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
circulating tumor cells level changes after radiotherapy		3 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival		3 years
disease-free survival		3 years
serum carcinoembryonic antigen (CEA) level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically verified rectal carcinoma
Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
the distance from anal verge <= 12cm
with or without metastasis
Age 18-75 years old
ECOG PS 0-2
No previous chemotherapy or radiotherapy for rectal carcinoma
Written informed consent

Exclusion Criteria:

no histologically verified rectal carcinoma
rectal cancer with stage I
distance from verge >12cm
age <=18 or >=75 years old
performed previously chemotherapy or radiotherapy
infection diseases within three months
serious other diseases
no written informed consent

Accepts Healthy Volunteers

Yes

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

rectal cancer diagnosed with stage II-IV

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenjie Sun, Master	Contact	86-21-64175590-1600		ganjumedecin@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	China	200032	China

References Module

Citations

Not provided

Label	URL
circulating tumor cells in colorectal cancer	View source
Circulating tumors cells as biomarkers: progress toward biomarker qualification	View source

ID	Term
D012004	Rectal Neoplasms
D009360	Neoplastic Cells, Circulating

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D011878	Radiotherapy
D000069287	Capecitabine

ID	Term
D013812	Therapeutics
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides