Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Fudan University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw); Radiation: radiation therapy

Study type: Observational

Funder types: Other

Identifiers

NCT01671891

SCRC-NM-1001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

rectal cancer with stage II-IV

Description:

rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin

Treatment:

Radiation: radiation therapy

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