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Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

This study is currently recruiting participants.
Verified August 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Zhen Zhang, Fudan University
ClinicalTrials.gov Identifier:
NCT01671891
First received: July 19, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Rectal Cancer
 Radiation: radiation therapy
Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • circulating tumor cells level changes after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • serum carcinoembryonic antigen (CEA) level [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • pathological response (tumor regression grade)if surgery [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • RECIST-based tumor response at 10 week after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Groups/Cohorts Assigned Interventions
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 Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

rectal cancer diagnosed with stage II-IV

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671891

Contacts
Contact: Wenjie Sun, Master 86-21-64175590-1600 ganjumedecin@hotmail.com

Locations
China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Wenjie Sun, Master     86-21-64175590     ganjumedecin@hotmail.com    
Principal Investigator: Zhen Zhang, PhD,MD            
Sub-Investigator: Wenjie Sun, Master,MD            
Sponsors and Collaborators
Fudan University
  More Information

Additional Information:
circulating tumor cells in colorectal cancer  This link exits the ClinicalTrials.gov site
Circulating tumors cells as biomarkers: progress toward biomarker qualification  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Zhen Zhang, director of radiotherapy department in Fudan university shanghai cancer center, Fudan University
ClinicalTrials.gov Identifier: NCT01671891     History of Changes
Other Study ID Numbers: SCRC-NM-1001
Study First Received: July 19, 2012
Last Updated: August 21, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
rectal cancer
circulating tumor cells
predict responses

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplastic Cells, Circulating
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
 Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013