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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Rectal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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preoperative concurrent chemoradiation

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.

Group Type EXPERIMENTAL

preoperative concurrent chemoradiation

Intervention Type RADIATION

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.

Interventions

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preoperative concurrent chemoradiation

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.

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No