Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- radiation therapy
- Conditions
- Rectal Cancer
- Sponsor
- Fudan University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- circulating tumor cells level changes after radiotherapy
- Last Updated
- 13 years ago
Overview
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.
Investigators
Zhen Zhang
director of radiotherapy department in Fudan university shanghai cancer center
Fudan University
Eligibility 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
Arms & Interventions
rectal cancer with stage II-IV
rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
Intervention: radiation therapy
rectal cancer with stage II-IV
rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
Intervention: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
Outcomes
Primary Outcomes
circulating tumor cells level changes after radiotherapy
Time Frame: 3 years
Secondary Outcomes
- 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)