Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

• Sponsor: Fudan University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01671891
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Radiation: radiation therapy; Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
• Study Start Date: Feb 1, 2012
• Anticipated Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
rectal cancer with stage II-IV rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin	Radiation: radiation therapy; 45-55Gy; Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw); radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin); Other Names: Xeloda

Outcome Measures

Primary Outcome Measures

1. circulating tumor cells level changes after radiotherapy [3 years]

Secondary Outcome Measures

1. overall survival [3 years]

2. disease-free survival [3 years]

3. serum carcinoembryonic antigen (CEA) level [3 years]

4. pathological response (tumor regression grade)if surgery [3 years]

5. RECIST-based tumor response at 10 week after radiotherapy [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• circulating tumor cells in colorectal cancer
• Circulating tumors cells as biomarkers: progress toward biomarker qualification

Publications

None provided.

• Responsible Party: Zhen Zhang, director of radiotherapy department in Fudan university shanghai cancer center, Fudan University
• ClinicalTrials.gov Identifier: NCT01671891
• Other Study ID Numbers: SCRC-NM-1001
• First Posted: Aug 24, 2012
• Last Update Posted: Aug 24, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Zhen Zhang, director of radiotherapy department in Fudan university shanghai cancer center, Fudan University: rectal cancer; circulating tumor cells; predict responses
• Additional relevant MeSH terms: Rectal Neoplasms; Neoplastic Cells, Circulating; Capecitabine; Oxaliplatin

Study Results

No Results Posted as of Aug 24, 2012