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Predicate | Object |
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rdf:type | |
lifeskim:mentions |
umls-concept:C0007113,
umls-concept:C0016360,
umls-concept:C0178602,
umls-concept:C0205195,
umls-concept:C0282460,
umls-concept:C0445550,
umls-concept:C0680730,
umls-concept:C1148554,
umls-concept:C1257890,
umls-concept:C1274040,
umls-concept:C1516985,
umls-concept:C1522449,
umls-concept:C1707491,
umls-concept:C2698651,
umls-concept:C2721771
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pubmed:issue |
10
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pubmed:dateCreated |
1993-11-8
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pubmed:abstractText |
In three consecutive phase II trials, 5-fluorouracil (5FU)-low dose leucovorin (20 mg/m2/day) was delivered in two 5-day courses during the first (d1 to d5) and the last (d29 to d33) week of a limited pelvic irradiation (45 Gy, 5 weeks, 25 fractions) in patients with locally extended rectal cancer. The three trials differed only by the 5FU dose in the chemotherapy (CT) schemes. In trial 1 (first CT course 5FU dose 425 mg/m2/day, second CT course 370 mg/m2/day), 16 patients were included. 5 patients suffered a grade 3+ toxicity and the compliance was 63%. In trial 2 (first and second CT course 5FU dose 370 mg/m2/day), 53 patients were included. 5 patients suffered a grade 3+ toxicity. The compliance was 94%. In the trial 3 (first and second CT course 5FU dose 350 mg/m2/day), 16 patients were included. 1 patient suffered a grade 3 toxicity and the compliance was 100%. The overall response rate (complete and partial responses) of local disease and distant metastasis were 87 and 7%, respectively. 43 patients were operated on after a mean delay of 8 weeks. Among the 41 macroscopic complete resections, 6 (14.6%) were sterilised and 12 (29.3%) were classified Asler-Coller A/B1. Regression curve analysis using either grade 3+ toxicity or incomplete treatment as an end point against the 5FU dose indicates that a 350 mg/m2/day 5FU dose is advisable for a phase III adjuvant multicentre trial.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:issn |
0959-8049
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
29A
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
1406-10
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pubmed:dateRevised |
2004-11-17
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pubmed:meshHeading |
pubmed-meshheading:8398268-Combined Modality Therapy,
pubmed-meshheading:8398268-Female,
pubmed-meshheading:8398268-Fluorouracil,
pubmed-meshheading:8398268-Humans,
pubmed-meshheading:8398268-Leucovorin,
pubmed-meshheading:8398268-Male,
pubmed-meshheading:8398268-Middle Aged,
pubmed-meshheading:8398268-Neoplasm Metastasis,
pubmed-meshheading:8398268-Patient Compliance,
pubmed-meshheading:8398268-Rectal Neoplasms,
pubmed-meshheading:8398268-Treatment Outcome
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pubmed:year |
1993
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pubmed:articleTitle |
Determination of the optimal dose of 5-fluorouracil when combined with low dose D,L-leucovorin and irradiation in rectal cancer: results of three consecutive phase II studies. EORTC Radiotherapy Group.
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pubmed:affiliation |
Radiotherapy Department, CHU Jean Minjoz, Besançon, France.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Clinical Trial, Phase II
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