Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

August 21, 2012 updated by: Zhen Zhang, Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Zhen Zhang, PhD,MD
        • Sub-Investigator:
          • Wenjie Sun, Master,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

rectal cancer diagnosed with stage II-IV

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
45-55Gy
Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years
disease-free survival
Time Frame: 3 years
3 years
serum carcinoembryonic antigen (CEA) level
Time Frame: 3 years
3 years
pathological response (tumor regression grade)if surgery
Time Frame: 3 years
3 years
RECIST-based tumor response at 10 week after radiotherapy
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion

December 7, 2022

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 24, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRC-NM-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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