Bone Marrow-sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer: An International Multicenter Phase II Clinical Trial (INTERTECC-2)
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F17%3A10367401" target="_blank" >RIV/00179906:_____/17:10367401 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.ijrobp.2016.11.027" target="_blank" >http://dx.doi.org/10.1016/j.ijrobp.2016.11.027</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ijrobp.2016.11.027" target="_blank" >10.1016/j.ijrobp.2016.11.027</a>
Alternative languages
Result language
angličtina
Original language name
Bone Marrow-sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer: An International Multicenter Phase II Clinical Trial (INTERTECC-2)
Original language description
Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) reduces acute hematologic and gastrointestinal (GI) toxicity for patients with locoregionally advanced cervical cancer. Methods and Materials: We enrolled patients with stage IB-IVA cervical carcinoma in a single-arm phase II trial involving 8 centers internationally. All patients received weekly cisplatin concurrently with once-daily IMRT, followed by intracavitary brachytherapy, as indicated. The primary endpoint was the occurrence of either acute grade >= 3 neutropenia or clinically significant GI toxicity within 30 days of completing chemoradiation therapy. A preplanned subgroup analysis tested the hypothesis that positron emission tomography-based image-guided IMRT (IG-IMRT) would lower the risk of acute neutropenia. We also longitudinally assessed patients' changes in quality of life. Results: From October 2011 to April 2015, 83 patients met the eligibility criteria and initiated protocol therapy. The median follow-up was 26.0 months. The incidence of any primary event was 26.5% (95% confidence interval [CI] 18.2%-36.9%), significantly lower than the 40% incidence hypothesized a priori from historical data (P = .012). The incidence of grade >= 3 neutropenia and clinically significant GI toxicity was 19.3% (95% CI 12.2%-29.0%) and 12.0% (95% CI 6.7%-20.8%), respectively. Compared with patients treated without IG-IMRT (n = 48), those treated with IG-IMRT (n = 35) had a significantly lower incidence of grade >= 3 neutropenia (8.6% vs 27.1%; 2-sided chi(2) P = .035) and nonsignificantly lower incidence of grade >= 3 leukopenia (25.7% vs 41.7%; P = .13) and any grade >= 3 hematologic toxicity (31.4% vs 43.8%; P = .25). Conclusions: IMRT reduces acute hematologic and GI toxicity compared with standard treatment, with promising therapeutic outcomes. Positron emission tomography IGIMRT reduces the incidence of acute neutropenia.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
International Journal of Radiation: Oncology, Biolology, Physics
ISSN
0360-3016
e-ISSN
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Volume of the periodical
97
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
536-545
UT code for WoS article
000393294900014
EID of the result in the Scopus database
2-s2.0-85009986044