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NCT01671891 Clinical Trial

Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01671891
Other study ID # SCRC-NM-1001
Secondary ID
Status Recruiting
Phase N/A
First received July 19, 2012
Last updated August 21, 2012
Start date February 2012
Est. completion date February 2013

Study information
Verified date August 2012
Source Fudan University
Contact Wenjie Sun, Master
Phone 86-21-64175590-1600
Email ganjumedecin@hotmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 2013
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Radiation:
• radiation therapy
45-55Gy
Drug:
• capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary circulating tumor cells level changes after radiotherapy 3 years Yes
Secondary overall survival 3 years Yes
Secondary disease-free survival 3 years Yes
Secondary serum carcinoembryonic antigen (CEA) level 3 years Yes
Secondary pathological response (tumor regression grade)if surgery 3 years Yes
Secondary RECIST-based tumor response at 10 week after radiotherapy 3 years Yes
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