Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study.

Details

Serval ID
serval:BIB_64D05F724F09
Type
Article: article from journal or magazin.
Collection
Publications
Title
Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study.
Journal
Annals of Oncology : Official Journal of the European Society For Medical Oncology
Author(s)
Machiels J.P., Duck L., Honhon B., Coster B., Coche J.C., Scalliet P., Humblet Y., Aydin S., Kerger J., Remouchamps V., Canon J.L., Van Maele P., Gilbeau L., Laurent S., Kirkove C., Octave-Prignot M., Baurain J.F., Kartheuser A., Sempoux C.
ISSN
0923-7534 (Print)
ISSN-L
0923-7534
Publication state
Published
Issued date
2005
Peer-reviewed
Oui
Volume
16
Number
12
Pages
1898-1905
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Journal ArticlePublication Status: ppublish
Abstract
BACKGROUND: Preoperative radiotherapy has been shown to decrease the local recurrence rate of patients with locally advanced rectal cancer. Capecitabine and oxaliplatin are both active anticancer agents in the treatment of patients with advanced colorectal cancer and have radiosensitizing properties. Therefore, these drugs would be expected to improve effectiveness of preoperative radiotherapy in terms of local control and prevention of distant metastases.
PATIENTS AND METHODS: Forty patients with rectal cancer (T3-T4 and/or N+) received radiotherapy (1.8 Gy, 5 days a week over 5 weeks, total dose 45 Gy, 3D conformational technique) in combination with intravenous oxaliplatin 50 mg/m2 once weekly for 5 weeks and oral capecitabine 825 mg/m2 twice daily on each day of radiation. Surgery was performed 6-8 weeks after completion of radiotherapy. The main end points were safety and efficacy as assessed by the pathological complete response (pCR).
RESULTS: The most frequent grade 3/4 adverse event was diarrhea, occurring in 30% of patients. pCR was found in five (14%) patients. According to Dworak's classification, good regression was found in six (18%) additional patients.
CONCLUSIONS: Combination of preoperative radiotherapy with capecitabine and oxaliplatin is feasible for downstaging rectal cancer.
Keywords
Adenocarcinoma/drug therapy, Adenocarcinoma/radiotherapy, Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Capecitabine, Combined Modality Therapy, Deoxycytidine/administration & dosage, Deoxycytidine/analogs & derivatives, Female, Fluorouracil/analogs & derivatives, Humans, Injections, Intravenous, Liver Neoplasms/secondary, Liver Neoplasms/therapy, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Staging, Organoplatinum Compounds/administration & dosage, Preoperative Care, Rectal Neoplasms/drug therapy, Rectal Neoplasms/radiotherapy, Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
20/10/2016 16:15
Last modification date
20/08/2019 14:21
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