Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Fudan University100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Rectal Cancer

Interventions

radiation therapyRADIATION

45-55Gy

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

radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China, China

RECRUITING

Outcomes

Primary Outcomes

circulating tumor cells level changes after radiotherapy

Time frame: 3 years

Secondary Outcomes

overall survival

Time frame: 3 years

disease-free survival

Time frame: 3 years

serum carcinoembryonic antigen (CEA) level

Time frame: 3 years

pathological response (tumor regression grade)if surgery

Time frame: 3 years

RECIST-based tumor response at 10 week after radiotherapy

Time frame: 3 years

Central Contacts

Wenjie Sun, Master

CONTACT

86-21-64175590-1600 ganjumedecin@hotmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.