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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: |
NCT00002896 |
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Date of registration:
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01/11/1999 |
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Primary sponsor: |
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Public title:
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Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer
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Scientific title:
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RANDOMIZED TRIAL OF CONCOMITANT PREOPERATIVE RADIO-CHEMOTHERAPY WITH OR WITHOUT POSTOPERATIVE CHEMOTHERAPY IN LOCALLY ADVANCED RECTAL CARCINOMA |
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Date of first enrolment:
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September 1993 |
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Target sample size:
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774 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00002896 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Luca Cionini, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ospedale Santa Chiara Pisa |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or mucinous
adenocarcinoma of the rectum Distal limit of tumor no higher than 12 cm from the anal
verge on proctoscopy Locally advanced (T3-4 M0) tumor by one of the following: Partial
fixation Complete stenosis Invasion beyond the muscular stratum on transrectal ultrasound
PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0 or 1 Hematopoietic:
WBC greater than 3,000 Platelets greater than 130,000 Hepatic: Not specified Renal:
Creatinine less than 1.4 mg/dL Cardiovascular: No unstable angina No cardiac
decompensation Other: No prior or concurrent malignancy
PRIOR CONCURRENT THERAPY: Not specified
Age minimum:
N/A
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: chemotherapy
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Drug: fluorouracil
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Drug: leucovorin calcium
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Procedure: conventional surgery
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Radiation: low-LET cobalt-60 gamma ray therapy
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Radiation: low-LET photon therapy
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Secondary ID(s)
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CDR0000065222
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CNR-9604
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EU-96047
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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