Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.
NCT ID: NCT01933568
Last Updated: 2019-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2013-02-28
2018-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiation
combined CFRT and SABR with concurrent cisplatin
SABR
combined CFRT and SABR with concurrent cisplatin
Cisplatin
combined CFRT and SABR with concurrent cisplatin
Interventions
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SABR
combined CFRT and SABR with concurrent cisplatin
Cisplatin
combined CFRT and SABR with concurrent cisplatin
Eligibility Criteria
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Exclusion Criteria
* WHO-performance status ≤ 2
* Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
* FEV1 and DLCO \> 40 % of the age-adjusted normal value
* Minimum required laboratory data bone marrow reserve and hepatic- and renal function
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Before patient registration, written informed consent must be given according to GCP and national regulations
* Patients with central tumors \< 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
* Patients that receive sequential chemoradiotherapy or radiotherapy only.
* Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
* Patients with Pancoast tumors
* Prior radiotherapy treatment to the thorax
* Any contraindications to the administration of thoracic radiotherapy
* Pregnant women
18 Years
ALL
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Heike Peulen, MD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
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The Netherlands Cancer Institute
Amsterdam, , Netherlands
Countries
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References
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Peulen H, Franssen G, Belderbos J, van der Bijl E, Tijhuis A, Rossi M, Sonke JJ, Damen E. SBRT combined with concurrent chemoradiation in stage III NSCLC: Feasibility study of the phase I Hybrid trial. Radiother Oncol. 2020 Jan;142:224-229. doi: 10.1016/j.radonc.2019.07.015. Epub 2019 Aug 17.
Other Identifiers
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N12HYB
Identifier Type: -
Identifier Source: org_study_id
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