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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01186081 |
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Date of registration:
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18/08/2010 |
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Primary sponsor: |
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Public title:
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Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
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Scientific title:
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Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01186081 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jong Hoon Kim, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed rectal adenocarcinoma
- Tumor located below 10 cm from the anal verge
- Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography
(EUS) and computed tomography (CT)
- Patients must be > 18 years and < 76 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow reserve
- Adequate renal function
- Adequate liver function
- Signed informed consent prior to randomization
Exclusion Criteria:
- Evidence of distant metastasis
- Previous history of chemotherapy or radiotherapy
- History of malignancy during recent 5 years other than skin cancer
- Pregnant or lactating woman
- Familial history of colorectal cancer
Age minimum:
19 Years
Age maximum:
75 Years
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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Radiation: Postoperative chemoradiotherapy
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Radiation: Preoperative chemoradiotherapy
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Primary Outcome(s)
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Disease-free survival
[Time Frame: Three year]
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Secondary Outcome(s)
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Local relapse-free survival
[Time Frame: Three year]
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Overall survival
[Time Frame: Three year]
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Sphincter preservation rate
[Time Frame: Three year]
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Treatment related toxicities
[Time Frame: Three year]
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Secondary ID(s)
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AMC Rectal Pre Vs Post 2004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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