Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

Study Overview
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Brief Summary
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Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.

Detailed Description
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Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.

Official Title
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Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: XELOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .endoscopy and biopsy verified rectal cancer within 12cm from anal verge; .primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer; .age from 20-75; .with informed consent; Exclusion Criteria: .refuse the further treatment after recruiting; .diagnosis of peritoneal metastasis in the surgery;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a group of patients receive 4 cycle of Xelox chemotherapy, MRI,TRUS, DE,endoscopy, blood DNA test,before, between and after chemotherapy was compared to detect the effect of chemotherapy in 2 cycles.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemotherapy group<br>patients receive 4 cycles of Xelox | Drug: XELOX<br>* Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor volume | tumor volume measured by MRI | At the end of Cycle 2 (each cycle is 3 weeks) | 
| tumor area in endoscopy | tumor area measured in endoscopy | At the end of Cycle 2 (each cycle is 3 weeks) | 
| tumor volume | tumor volume measured by MRI | At the end of Cycle 4 (each cycle is 3 weeks) | 
| tumor area in endoscopy | tumor area measured in endoscopy | At the end of Cycle 4 (each cycle is 3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood DNA test | blood DNA test | At the end of Cycle 2 (each cycle is 3 weeks) | 
| blood DNA test | blood DNA test | At the end of Cycle 4 (each cycle is 3 weeks) | 
| tumor thickness in TRUS | tumor thickness in TRUS | At the end of Cycle 4 (each cycle is 3 weeks) | 
| tumor thickness in TRUS | tumor thickness in TRUS | At the end of Cycle 2 (each cycle is 3 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer；, neoadjuvant Chemotherapy