Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

Study Overview
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Brief Summary
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The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.

Detailed Description
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For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.

Official Title
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Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Radiation: preoperative concurrent chemoradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0). Distance from the lower bound of tumor to the anal verge is less than 12 cm. KPS score not less than 70 Can be tolerated chemotherapy and radiotherapy. No history of radiation therapy to the pelvis. Non-allergic history of fluorouracil or platinum-based chemotherapy drugs. Full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. - Exclusion Criteria: Other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). Pregnant or lactating patients. Fertility but did not use contraceptive measures. Existing active infection. Merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. Concurrent treatment with other anticancer drugs. Can not complete treatment or follow-up

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative concurrent chemoradiation<br>Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation. | Radiation: preoperative concurrent chemoradiation<br>* Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression in different response groups |  | 6 months after radical surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, disease free survival and local-regional free survival |  | 3 years after pre-operative chemoradiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal carcinoma, preoperative concurrent chemoradiotherapy