Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

NCT ID: NCT01671891

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Rectal Cancer

Keywords

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rectal cancer circulating tumor cells predict responses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rectal cancer with stage II-IV

rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin

radiation therapy

Intervention Type RADIATION

45-55Gy

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

Intervention Type DRUG

radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)

Interventions

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radiation therapy

45-55Gy

Intervention Type RADIATION

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

radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhen Zhang

director of radiotherapy department in Fudan university shanghai cancer center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, China, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjie Sun, Master

Role: CONTACT

Phone: 86-21-64175590-1600

Email: [email protected]

Facility Contacts

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Wenjie Sun, Master

Role: primary

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/22230943

circulating tumor cells in colorectal cancer

http://www.ncbi.nlm.nih.gov/pubmed/22157288

Circulating tumors cells as biomarkers: progress toward biomarker qualification

Other Identifiers

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SCRC-NM-1001

Identifier Type: -

Identifier Source: org_study_id