Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01671891

Enrollment

100

Registered

2012-08-24

Start date

2012-02-29

Completion date

2013-02-28

Last updated

2012-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer, circulating tumor cells, predict responses

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.

Interventions

RADIATIONradiation therapy

45-55Gy

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

radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
circulating tumor cells level changes after radiotherapy	3 years

Secondary

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

Countries

China

Contacts

Primary ContactWenjie Sun, Master

ganjumedecin@hotmail.com86-21-64175590-1600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026