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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-15006683 |
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Date of registration:
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2015-06-30 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Preoperative short-course radiotherapy with local boost versus conventional preoperative short-course radiotherapy for local advanced rectal cancer: phase II clinical trail
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Scientific title:
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Preoperative short-course radiotherapy with local boost versus conventional preoperative short-course radiotherapy for local advanced rectal cancer: phase II clinical trail |
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Date of first enrolment:
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2015-07-01 |
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Target sample size:
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study group:50;control group:50; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=11329 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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II (Phase II study)
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Countries of recruitment
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China
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Contacts
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Name:
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Zhou Fuxiang
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Address:
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169 Donghu Road, Wuhan, China
430001
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Telephone:
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+86 18971252780 |
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Email:
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happyzhoufx@sina.com |
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Affiliation:
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Zhongnan Hospital of Wuhan University |
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Name:
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Zhou Fuxiang
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Address:
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169 Donghu Road, Wuhan, China
430001
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Telephone:
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+86 18971252780 |
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Email:
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happyzhoufx@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Local advanced rectal cancer (TNM Stage: T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography;
2. Distance between tumour and anal edge <=12cm;
3. PS (Performance Status) score 0-2 or Karnofsky score >=70;
4. Liver and kidney functions are normal;
5. Without any anticancer treatment before inclusion.
Exclusion criteria: 1. Metastasis;
2. Combined with other severe diseases, such as other kind of cancer, COPD, Miocardial infarction, ect.;
3. Included in other clinical trails.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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rectal cancer
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Intervention(s)
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study group:preoperative short-course radiotherapy with local boost;control group:preoperative short-course radiotherapy without local boost;
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Primary Outcome(s)
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Pathological complete remission rate;
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Secondary Outcome(s)
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Sphincter preservation rate;toxicity of radiotherapy;
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Source(s) of Monetary Support
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Zhongnan Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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