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Onderzoek naar het vrijwillig adem inhouden tijdens de bestraling voor alvleesklierkanker voor nauwkeuriger bestraling


- candidate number15884
- NTR NumberNTR4317
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-dec-2013
- Secondary IDs15884 NTR is the first
- Public TitleOnderzoek naar het vrijwillig adem inhouden tijdens de bestraling voor alvleesklierkanker voor nauwkeuriger bestraling
- Scientific TitleFeasibility of breath-hold techniques in irradiation of pancreatic cancer, a pilot study
- ACRONYMBREATHPANC
- hypothesisBreath hold techniques may pose an advantage over free breathing techniques for irradiation of pancreatic cancer
- Healt Condition(s) or Problem(s) studiedBorderline personality disorder , Resectable pancreatic carcinoma, Radiotherapy
- Inclusion criteria- Patients with pancreatic cancer, locally advanced or (borderline) resectable status, who are treated with radio(chemo)therapy;
- WHO performance status of 0-2;
- Written informed consent.
- Exclusion criteria- Inability to undergo the additional treatment planning CT scan and fluoroscopy;
- Serious lung condition precluding breath-hold
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-sep-2015
- Target number of participants10
- InterventionsNo additional therapeutic interventions During preparatory CT and once weekly during fractionated radiation, additional imaging shall be performed in breath hold conditions.
- Primary outcomeComparison of preparatory, inter and intra fraction tumour motion between free breathing and breath hold conditions
- Secondary outcome- Feasibility of irradiation in breath hold conditions
- Calculation of change in margins in breath hold conditions compared to free breathing
- Calculation of potentially resulting changes in normal tissue complication probability (NTCP)
- Timepoints- Acquirement of data before and during treatment of patients giving informed consent
- Analysis of all data untill 3 months after closure of accrual
- Interpretation of data and making manuscript within 6 months after closure of accrual.
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G. Tienhoven, van
- CONTACT for SCIENTIFIC QUERIESDr. G. Tienhoven, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, Self Funding
- PublicationsN/A
- Brief summaryPilot study of 10 patients with pancreatic cancer eligible for radiochemotherapy for (borderline) resectable or irresectable pancreatic cancer to investigate whether irradiation with a breath hold technique is feasible, and leads to less inter fraction position variation and intra fraction motion, than free breathing methods.
- Main changes (audit trail)
- RECORD15-dec-2013 - 3-jan-2014


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