Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC
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|ClinicalTrials.gov Identifier: NCT02059967|
Recruitment Status : Withdrawn (Due to no accrual.)
First Posted : February 11, 2014
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Lung Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer||Drug: Paclitaxel Radiation: image-guided adaptive radiation therapy Drug: carboplatin||Phase 1|
OUTLINE: This is a dose-escalation study of IGART.
Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
After completion of study treatment, patients are followed up periodically for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)
Patients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
Other Name: 5beta,20-epoxy-1,2alpha,4,7beta,10beta, 6,12b-bis(acetyloxy)-12-(benzoyloxy)-1a,33,4,-4, Anzatax, Asotax, Bristaxol, Praxel, TAX, Taxol, Taxol Konzentrat
Radiation: image-guided adaptive radiation therapy
Other Name: IGART, image-guided adaptive radiotherapy
- MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity [ Time Frame: 3 months ](using daily image-guidance, deformable image registration, adaptive replanning at defined time points, and dose intensification at normal tissue tolerance) of radiotherapy delivered concomitantly with standard chemotherapy.
- Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0 [ Time Frame: Up to 90 days from radiation therapy start ]Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
- Incidence of late toxicity measured using the Radiation Therapy Oncology Group Late Radiation Morbidity Scoring [ Time Frame: Up to 5 years ]Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
- Practicability of the approach [ Time Frame: Up to 5 years ]Variations in respiratory patterns, tumor and CTV positions, as well as tumor volumes will be assessed on the respective under-treatment imaging studies. The feasibility of deformable image registration will be benchmarked against manual contours of targets and normal tissue. The practicability of IGART will be measured by assessing the necessary time, IT and personnel resources needed to conduct the study.
- Tumor response evaluated according to Response Evaluation Criteria in Solid Tumors v1.1 [ Time Frame: Up to 15 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059967
|Principal Investigator:||Elisabeth Weiss, MD||Virginia Commonwealth University|