Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT01671891
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description rectal cancer with stage II-IV radiation therapy rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin rectal cancer with stage II-IV capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw) rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
- Primary Outcome Measures
Name Time Method circulating tumor cells level changes after radiotherapy 3 years
- Secondary Outcome Measures
Name Time Method serum carcinoembryonic antigen (CEA) level 3 years pathological response (tumor regression grade)if surgery 3 years overall survival 3 years RECIST-based tumor response at 10 week after radiotherapy 3 years disease-free survival 3 years
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China